market access market access JULY/08/AUG

market market access access JulY/08/aug 

www.us.tuv.com 

www.tuv.com 

Your KeYs to NatioNal aNd iNterNatioNal CompliaNCe 

Global market access 

simplifyinG the certification process 

at the local level 

The Inside View 2 

Overview From Our International 

Approvals Manager 

Cover Story: 3 

International Approvals 

Global Market Compliance 

Late-Breaking News 6 

Worldwide Certification Agency 

Acquires Unified Testing Services 

In Alabama 

Product Safety 8 

REACH And The Value Of The 

Impact Analysis 

Medical 9 

Update on FDA’s Third Party 

Inspection Program And pMAP 

Quality 14 

Announcing The Monthly Customer 

Feedback Survey Winners 

Functional Safety Seminar 15 

Hardware / Software Design 

To IEC 61508 

TÜVRheinland ® Resources 17 

Tradeshows / Seminars

market access JulY/08/aug 

The Inside View 

Dear Valued Customers, 

Whether it is a toy, household appliance, machinery, medical, 

radio communications or telecommunications equipment, 

market access is heavily regulated in most countries in the 

world. The mandatory compliance procedures vary from 

a manufacturer’s Declaration of Conformity with market 

surveillance to Mandatory Certification within the country, 

accompanied with regular follow-up inspections. Though 

steps are taken to harmonize the certification process, the 

simple goal of one product, one test, accepted everywhere; 

a target of trade liberalization is far from being realized. 

Preparing a product for compliance in the global market 

requires understanding and mastering the complexities of 

the regulation and requirements specific to each country. In 

the electrical and electronic sector for example, aside from 

safety and EMC requirements, there are also regulations 

for ergonomics, health, hygiene, noise, vibration, waste 

disposal, restrictions on the use of chemicals or other 

substances, wired and wireless telecommunications and 

energy performance. Strong expertise is necessary to be 

familiar with and stay abreast of the changing regulations 

and requirements, especially when trying to penetrate 

multiple countries. 

With a global network of 300 locations in 52 countries, 

TüVRheinland ® understands the challenges of obtaining 

global market access. In fact, TüVRheinland ® collaborates 

with many of the world’s top level companies to keep them 

on the cutting edge. The market access service experts are 

trained to deal with worldwide certification issues and keep 

abreast of the ever changing requirements. 

In this issue of Market Access, the cover story reviews 

the global compliance issues for market access in detail. 

You will also find articles on topical issues exploring the 

impact of the European REACH regulation and FDA’s Third 

Party Inspection Program and pMAP. In addition, discover 

timely news items, such as the upcoming Functional Safety 

seminar, tradeshows and more. 

Sincerely, 

Peter Merguerian 

International Approvals Manager 

Peter Merguerian 

InTERnATIOnAl APPROVAlS MAnAGER 

TüVRheinland ®

market access 

Cover Story 


Global Market Compliance 

A Local Approach Eases A Complicated Process 

Authored by Udo Heinz, (Carlsbad, CA) Division Manager of Industrial Machinery and Sky Mehringer, 

(Carlsbad, CA) Senior Technical Coordinator for International Approvals 

Helping a product achieve global compliance is 

widely considered a complicated and time-intensive 

process. To place a product in other countries, 

manufacturers must maneuver a complicated maze 

of compliance requirements. A single harmonized 

worldwide standard does not yet exist. 

preparing for Global compliance 

Global compliance is required whether a company is 

launching a consumer product or installing machinery 

in another country. To prepare, there are several key 

considerations, starting with the R&D phase. 

• First, research the country’s electrical ratings and 

design concerns, or hire a compliance agency to 

help with that process. Design the product so that 

it works overseas by taking into account of each 

country’s required electrical ratings. 

ConTInUeD on pAge 4 

JulY/08/aug 

• Second, if the product is classified for telecommunications, 

find out which frequency bands are 

allowed. 

• Third, contact each country’s local regulatory 

authority to determine certification requirements 

and procedures. Several consulting companies 

like TüVRheinland ® have local contacts for dozens 

of countries, and can handle this step more efficiently. 

• Fourth, contact a global compliance agency for 

product testing and certification. The agency will 

work with the local regulatory agencies to test and 

certify the product. Depending on the country and 

the product in question, certification can be processed 

through a local national Certification Body 

or must be completed through the local regulatory 

(government) agency. 

certifying the Written Word 

When testing and certifying a product, nothing is 

overlooked, including the product’s user manual, 

labels, warnings, test reports, schematics, etc. Each 

country has varying requirements but they all have 

one thing in common: documents must be written 

accurately – with no misleading statements.


Cover Story 


Global Market Compliance (continued) 

In some countries, the product’s associated 

documents must be written in the local language. 

For example, Taiwan requires Simple Chinese as 

opposed to Mandarin Chinese. In some cases, a local 

compliance agency can assist with translation or will 

accept an English manual for testing and certification 

purposes with the guarantee that a local language 

manual will be provided with the imported product. 

A local compliance agency can translate these 

documents for the manufacturer – another benefit of 

having a local office. 

Additionally, all documents must display the product’s 

appropriate warnings and ratings. Rating labels 

are reviewed especially closely to ensure it has 

the correct ratings, safety warning and certificate 

numbers to pass through customs. 

budgeting time for the certification process 

When launching a product globally, manufacturers must 

prepare to work with either the country’s government or 

a local regulatory agency. A country can require multiple 

preliminary steps for certification, which can extend the 

certification process altogether. 



The lead time for certifying a product varies 

depending on the product, country and whether 

certification is through a government authority or 

through a national Certification Body with a local 

office. Certifying your product can take anywhere 

from 1 week to 3 months, sometimes longer if it’s 

through a government authority or there are issues 

with the product passing. 

In China, for example, the manufacturer must 

have its product tested for EMC by a government 

lab. The manufacturer can submit a safety report 

and certificate (CB scheme) to the government’s 

regulatory agency. However, the government must 

test product samples in its own test laboratories for 

the product to receive the China CCC certification 

mark. The timeframe for this entire process depends 

on the length of the testing cycle and the product’s 

ability to pass government testing without issues. 

Furthermore, all telecommunications products must 

be tested in-country in China for telecom approval. 

local expertise 

It is a very daunting task to meet compliance in 

the global market. Even if you have the technical 

understanding of the process, certifying a 

product worldwide requires familiarity with the 

local country’s regulations, processes and even 

government contacts. Therefore, in-country 

personnel will bring an insider’s approach, helping 

smooth the path toward global compliance. 

Moreover, in many cases local representation is 

required by law to obtain an approval certificate 

for a product. Until the day when global compliance 

becomes harmonized, taking the local route – one 

day and one country at a time – yields the most 

success.


Cover Story 


Global Market Compliance (continued) 


A locally affiliated compliance group or office can 

ease the path to compliance in numerous ways. Often 

staffed by local citizens, these offices hold the top 

experts on the country’s regulatory issues, processes 

and agencies. These individuals are also familiar with 

the local language, dialects, customs and politics. 

In many ways, a local contact helps improve overall 

cost and time savings. The in-country contact can 

communicate directly with the regulatory agency (or 

in some cases, government ministry) much more easily 

than someone in another time zone. As an accessible 

liaison to the government, this person can help with 

on-site, in-country product inspections. Depending 

on the country, a regulatory body will either perform 

its own electrical inspections or accept technical 

reports from a national Certification Body (nCB), or 

the government requires in-country auditors to inspect 

the product and coordinate inspections for electrical 

compliance. In both cases, a local compliance contact 

can help smooth the path toward global compliance. 

For more information and to learn more about 

compliance regulations in the global market, please 

call 1-tUv-rheinlanD (1-888-743-4652).


Late-Breaking News 

Worldwide Certification Agency Acquires Unified Testing 

Services In Alabama 

Celebrating new acquisition - Bernie Hrubala, Division Manager 

peMT, Don Uptain, president of UTS, Stephan Schmitt president 

and Ceo TÜVRheinland ® of north America, Denny Stepp, Vice 

president of UTS, Deep Krishnan Vice president of operations, 

TÜVRheinland ® of north America. 

TüVRheinland ® recently acquired Unified Testing 

Services, Inc. (UTS), a full-service testing and 

consulting engineering firm based in Woodstock, 

Alabama. TüVRheinland ® currently serves many 

industry sectors globally and this strategic acquisition 

will benefit clients with added expertise, geographic 

expansion of coverage and an increase of service 

portfolio offerings to additional industry sectors. 

The UTS client base includes many diverse groups 

including: state departments of transportation; 

universities; banking and real estate institutions; 

paper and steel mills; power plants; fabrication 

and machine shops; automobile industry suppliers; 

industrial equipment suppliers; steel fabrication 

shops; amusement/theme parks; and state and local 

governments. 



“This acquisition enhances our ability to serve 

additional segments in different industries that we 

have not served in north America before. Previously, 

we had offered our services in this industry segment 

for export to the rest of the world. now we can offer 

these services for the north American market, which is 

huge benefit to our clients. Having this significant local 

expertise will complement our global proficiencies 

and provide a better network that will benefit local 

customers.” says Stephan Schmitt, President and CEO 

of TüVRheinland ® of north America. 

UTS brings extensive expertise in a wide variety 

of testing and inspection services focused on 

materials, construction, transportation, facilities and 

environmental engineering. Overall, services include: 

environmental consulting and testing; destructive and 

non-destructive materials testing; and shop fabrication 

inspection of structural steel bridges. 

In the environmental arena, UTS provides quality, 

cost-effective environmental and testing services that 

include testing, sampling and analysis of paints for lead 

concentration, as well as assessment and observation 

of lead–based paint. The staff is trained in a full range 

of asbestos identification and management services 

consisting of facility surveys and assessments, 

abatement design, abatement monitoring and laboratory 

analysis. A full range of environmental site assessment 

services ranging from “due diligence” assessments 

for real property transactions to sampling and testing 

can be offered. UTS also has the capability to provide 

indoor air quality testing and assessment (covering


Late-Breaking News 

both airborne and microbiological contaminant 

sampling and analysis); underground – and – above 

ground storage tank assessment and management; 

and management and storm water permitting. 

UTS can greatly aid production part inspection needs 

with computed radiography in addition to other nondestructive 

testing (nDT) methodologies: visual; 

ultrasonic; magnetic particle; and liquid penetrant 

inspections to any code or specification. This wide 

range of nDT techniques and procedures supports 

clients in an industrial atmosphere including “outagetype” 

situations. Services include annual boiler 

inspections, critical piping and pressure vessel 

inspections, or mechanical integrity verification. 

Personnel have experience working with pulp and 

paper, power plants, chemical refineries and bulk 

storage facilities. A full service lab is located near 

many automotive manufacturers, as well as, support 

industry for defense contractors. 


Worldwide Certification Agency Acquires Unified Testing Services In Alabama (continued) 

Another key element of the merger is a synergistic 

view of the importance of quality service. In a recent 

customer satisfaction survey, 98% of TüVRheinland ® 

customers stated that they were very satisfied with 

the service they received. UTS has always shown 

a commitment to the highest quality possible in the 

services that they provide. 

“I am very pleased with our merger with 

TüVRheinland ® . We are now part of the premier 

global testing and certification company having 

offices in over 60 countries. This is remarkable and 

says much about the quality of our company. We 

can be proud of our past and look forward to our 

future with TüVRheinland ® . Over the last 15 years, 

UTS faced many challenges and opportunities as 

our company grew and our markets changed. Our 

competitive markets will continue to change and now, 

as part of TüVRheinland ® we can take advantage of 

the opportunities that are coming. We are now more 

than a regional Southeastern U.S. company and our 

services can be provided throughout the United 

States, Canada, and Mexico” says Don Uptain, 

President of Unified Testing Services. 

This acquisition will be beneficial to all parties, but 

most importantly to our collective customers who 

will benefit from the added industry solutions we can 

now deliver with consistent high quality. 

To learn more, please call 1-tUv-rheinlanD 

(1-888-743-4652).


Product Safety 

REACH And The Value Of The Impact Analysis 

Authored by geoffrey Bock, (Detroit, MI) RoHS/Weee Manager 

The EU has implemented a new chemicals regulation 

called REACH, which stands for Regulation, Evaluation, 

Authorization, and restriction of CHemical substances. 

The new regulation is replacing over 40 pieces of 

existing legislation. Manufacturers, importers and 

users will now have the responsibility of managing the 

risks posed by chemicals. REACH will be coordinated 

and implemented by the European Chemicals Agency 

(ECHA) located in Finland. 

Manufacturers and importers, up and down the supply 

chain will be responsible for registering chemicals. 

Chemicals in preparations or articles manufactured or 

imported in excess of 1 ton will be required to register. 

What does this mean for non-european producers? 

Businesses can be adversely impacted by REACH; 

supply chains can be disrupted and you can lose 

market access in the EU. Companies that understand 

the business implications and impacts of REACH, and 

develop strategic action plans, will gain a competitive 

edge over those that fail to do so. 

Pre-registration will apply to phase-in substances. 

There will be a 6-month window from June 1, 2008 to 

november 30, 2008. Failure to pre-register will result 

in a loss of pre-registration phase-in status; which will 

result in a full 12 month registration process. 

What tÜvrheinland ® can do for you: 

• Comprehensive REACH analysis regarding manufacturer’s 

products and how they are impacted by 

the current legislation 


• On-site educational session 

• Review of sales channel and products 

• Recommendations of supply channels 

• Collection of course data required for preregistration 

• Written list of responsibilities for each chemical 

• Written list of responsibilities for client 

• Profile of timelines and deadlines of requirements 

pertaining to each chemical 

• Recommended approach of terms and conditions 

of sale 

• Pre-registration prepared for each chemical with 

the EU Chemical Agency 

• 3 months of on-call monthly consulting from 

project start 

• Q&A support from experts in global environmental 

requirements 

how you can benefit from tÜvrheinland ® services: 

• Expertise on EU legislation and REACH implementation 

• Avoiding withdrawal of product constituents due 

to lack of fulfilling registration requirements 

• Receive an Impact Analysis of your business situation 

and learn how to reduce effort and costs 

For more information, please call 1-tUv-rheinlanD 

(1-888-743-4652).


Medical 

Update on FDA’s Third Party Inspection Program and pMAP 

Authored by gregor Dzialas, (Boxborough, MA) Third party Inspection program Manager 

The Medical Device User Fee and Modernization 

Act of 2002 (MDUFMA) introduced the Inspection 

by Accredited Person Program. Under this program 

eligible manufacturers of class II and III medical 

devices can choose to use an FDA accredited third 

party, such as TüVRheinland ® of north America, to 

perform inspections to US regulations as an alternative 

to the traditional inspection by an FDA official. The 

primary benefit for manufacturers to participate in this 

voluntary program is to combine FDA inspections with 

other conformity assessment inspections, e.g. MDD/ 

ISO 13485/CMDCAS, which will save time, money and 

resources. 

The MDUFMA of 2002 established a new subsection of 

the US Food, Drug and Cosmetic Act, which required 

FDA to accredit third parties to perform inspections of 



eligible device manufacturers. The program is referred 

to as “Inspection by Accredited Person Program” 

or “Third Party Inspection Program”. An Accredited 

Person (AP) under the provisions of this Program is a 

third party recognized by FDA to: 

• Assess the quality system of eligible manufacturers 

of Class II and III devices under 21 CFR Part 820 

• Determine compliance with other device requirements 

in the act and regulations 

• Prepare and submit reports to FDA, who makes the 

final compliance assessment 

By statute the FDA has the mandate to inspect class II 

and III device manufacturers every two years. Due to 

FDA’s limited resources and the global expansion of the 

medical device industry, actual inspection frequency 

(especially for lower risk device manufacturers 

and foreign manufacturers) is much lower than the 

biennial inspection requirement. In a report issued 

by the US Government Accountability Office (GAO) in 

January 2008, it is stated that the FDA estimates that 

establishments for medium risk devices have been 

inspected every 5 years and foreign establishments 

involved with medium risk devices every 27 years. The 

AP inspection program will allow the FDA to focus on 

higher-risk inspections, and those inspections which 

are not within the scope of the program, such as “forcause”, 

PMA and bioresearch monitoring inspections. 

Conversely, manufacturers with a global marketing 

presence have been faced with ever increasing 

number of regulatory requirements and conformity 

assessments. To maintain their market presence, they 

must undergo numerous separate inspections each


Medical 

Update on FDA’s Third Party Inspection Program and pMAP (continued) 

year to demonstrate compliance with requirements 

that are largely harmonized. Participation in the Third 

Party Inspection Program will give manufacturers 

the opportunity to reduce the number of inspections 

conducted to meet FDA and other countries’ regulations, 

and to control the scheduling of inspections. 

pmap – pilot multi-purpose audit program 

The pilot Multi-purpose Audit Program, which was 

developed by Health Canada (HC) in cooperation 

with the US Food and Drug Administration (FDA), was 

introduced in September 2006. The purpose of the 

pMAP is to evaluate the effectiveness of performing a 

single third party inspection/audit of medical devices 

manufacturers’ quality management systems that 

would meet the regulatory requirements of Canada 

and the United States. The pMAP builds upon the 

regulatory programs of both countries, specifically 

those aspects which involve the services of third 

party quality system auditing organizations: the FDA’s 

Inspection by Accredited Person Program and Health 

Canada’s CMDCAS program. FDA and HC are intending 

to use the audits/inspections under the pMAP as a 

learning opportunity to acquire a better knowledge of 

auditing/inspection approaches that support several 

regulatory objectives. 



10 

While pMAP does not alter or eliminate any previously 

established procedures, guidance and regulations of 

the AP and the CMDCAS program, it is a program in 

itself, which has its own set of rules and requirements. 

It is important to note that at the current time, the pMAP 

is mandatory for manufacturers who are seeking a 

single inspection/audit under the CMDCAS and AP 

program. 

progress and status of the ap and pmap programs 

According to a report by GAO, few inspections of 

medical device manufacturing establishments have 

been conducted through the AP Inspection Program 

and the pMAP. From March 11, 2004 - the date when 

FDA first cleared an accredited organization to 

conduct independent inspections - through January 

2008, only five inspections were conducted under the 

AP program and two audits under the pMAP. These 

numbers seem to suggest a very limited interest in 

these programs, but a close look at the history and the 

rules of both programs might reveal other reasons for 

the low participation. 

While the FDA met their objective to initially accredit 

15 third parties by October 2003, very slow progress 

has been made in qualifying individual inspectors/ 

auditors in this program. According to the current 

program rules, each auditor has to participate in three 

joint inspections with the FDA. The demand in joint 

inspections is higher than the number of inspections 

offered; the FDA assigns the inspections to APs by a 

random draw. The availability of training opportunities 

is limited by the number of device manufacturers, 

who volunteer to host joint inspections. Training is 

also limited by the availability of FDA performance 

inspectors, who are qualified to monitor AP auditors


Medical 


during joint inspections. The limited availability of 

training inspections makes it difficult for APs to plan 

the qualification of auditors and subsequently offer 

third party inspection services. Today, as a result, only 

eight of the 16 accredited third parties are operational 

and can offer independent inspections. Of those eight 

APs, four are located in the United States; among them 

is TüVRheinland ® of north America, Inc. 

Another reason for the low participation in the program 

could be the restrictive eligibility requirements. 

Excluded from participation are device manufacturers, 

who have not been inspected by the FDA (baseline 

inspection) or whose last inspection has been 

qualified as OAI (Official Action Indicated). Also, the 

manufacturer must market or intend to market a device 

in a foreign country, in which the AP is accredited or 

recognized. Per the FDA website, some APs appear 

to be recognized in very few countries. For example, 

one of the APs is recognized only in norway. The 

pMAP program has further narrowed the eligibility for 

manufacturers. Audits that are not acceptable under 

the pMAP program are: 

• Initial ISO 13485:2003 registration audits under 

CMDCAS 

• Transfer of registration from one audit organization/registrar 

to another 



11 

• Audits to support an extension to the existing 

scope of registration 

• Special “for-cause” audits (e.g. re-audits to follow-up 

on major non-conformities) 

lastly, while these programs are designed to offer clear 

benefits to device manufacturers, participation calls 

for a mind-set adjustment relating to FDA inspection. 

While manufacturers always had to “invite” CMDCAS 

registrars and notified Bodies for an audit in order to 

market their products in Canada and the EU, this is not 

necessary or required in the US: Pre-market approval 

or pre-market notification clearance is sufficient in 

order to market a product. The FDA decides if and when 

to inspect an establishment involved in the product 

realization of a device. To invite an FDA/AP inspection, 

which otherwise might not be conducted, is a very new 

and pro-active approach. 

The FDA and HC have realized these challenges 

in the AP program and have taken measures to 

improve participation. The Medical Device User Fee 

and Modernization Act (MDUFMA II) - legislative 

Recommendations (April 30, 2007) includes proposals 

for the following changes: 

• Streamline administrative burdens 

- Firms would provide FDA 30 day notice of their 

intent to use an AP rather than petitioning FDA 

for clearance to use an AP 

• Expand participation 

- Firms may use an AP for an unlimited number of 

consecutive inspections without seeking a waiver, 

rather than only two consecutive inspections 

- FDA would continue to conduct “for cause” or 

follow-up inspections at their discretion


Medical 

• Encourage industry to provide FDA with more data 

- Firms may voluntarily submit reports by third 

parties assessing conformance with appropriate 

international quality systems standards, such as 

ISO, which FDA would consider in setting our 

inspectional priorities 

In addition, Health Canada and the FDA undertook 

a cooperative effort to identify those device 

manufacturers in the US, who are due for an 

FDA inspection in 2008 and at the same time are 

registered to ISO 13485 under the CMDCAS program. 

Manufacturers who met both criteria received a 

mailing with information about the pMAP program 

and were encouraged to participate. 

Most recently an increase of interest and participation 

in the program has been observed. In the Health 

Canada CMDCAS RBF (Registration Body Forum) 

meeting in May 2008 it was stated that already five 

companies have been successfully assessed under 

the pMAP process. Both Health Canada and the FDA, 

which also participated in this meeting expressed that 

they remain committed to the program and agreed that 

a sample size of 10 successful pMAP audits would be 

considered “sufficient experience” to assess the results 




of this pilot program. If the assessment concludes that 

multi-purpose audits are valid and acceptable to fulfill 

the requirements under the CMDCAS program, then 

some of the restrictions for participation might be 

eliminated. 

Another very promising objective, which came out of 

this meeting, is the development of a common audit/ 

inspection report format. A common report format 

would significantly reduce the time needed by the AP/ 

Registrar to prepare the two submissions and hence 

would reduce the additional service fees associated 

with AP/pMAP audits. 

Who should participate and why? 

Manufacturers who are likely to be inspected by the 

FDA and who market products in foreign countries will 

benefit from participation in the AP and pMAP program 

because they will reduce the overall number of audits/ 

inspections conducted at their establishment and they 

will gain more control over the timing and planning of 

the audit/inspection. 

Manufacturers who in the past have not been inspected 

at two year intervals might want to consider an AP 

inspection for another reason: Historic data shows 

that regularly inspected establishments are more 

likely to be found in compliance with the regulations. 

By requesting an AP inspection on a regular basis, 

manufacturers can increase the confidence in their 

quality management system and its conformance to 

the US regulations. 

Finally, manufacturers that are not currently eligible 

under the program, or do not wish to participate at 

this time, are encouraged to volunteer to host joint 

1


Medical 


inspections by the FDA and a Third Party. In particular, 

those manufacturers who have received notification 

from the FDA that they are due for an inspection can 

greatly help to advance this program by allowing a 

third party auditor to join on their next FDA inspection. 

Manufacturers who decide to volunteer for joint 

inspections should contact the FDA and their registrar/ 

notified body to request that the joint inspection is 

conducted by an auditor who works for this particular 

manufacturer’s registrar/notified body. This will assure 

that independent third party inspections will be a 

possibility for them in the near future. 

conclusion 

The Inspection by Accredited Person Program and the 

pilot Multi-purpose Audit Program are operational, and 

successful audits/inspections have been conducted 

under both programs. However, more participation is 

required to keep these programs alive. 

FDA and Health Canada remain committed and have 

proposed changes and initiatives to promote and 

advance both programs. 

For more information, please call 1-tUv-rheinlanD 

(1-888-743-4652). 

references 

FDA AP program website: 

http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html 

FDA guidance document: 

“Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons 

Program Authorized by Section 203 of the Medical Device User Fee and Modernization Act of 

2002 – Draft, June 3, 2002” 

http://www.fda.gov/cdrh/comp/guidance/1532.html 

Health Canada website: 

Pilot Multipurpose Audit Program (PMAP) - Questions and Answers related to the Pilot 

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/md_pmap_qa_im_ppafm_qr-eng.php 


1


Quality 

Congratulations to Weylan Stricklin from nachi 

Robotic - the April winner and Mike Benson from 

Associated Spring, Barnes Industrial- the May winner 

of TüVRheinland ® ’s customer feedback survey drawings 

for the Management System Certification (MSC) 

Division. Weylan and Mike are proud winners of an 

elegant TüVRheinland ® clock, which was recently sent 

to them, compliments of TüVRheinland ® . 

Providing customer service is critical to the MSC 

Division of TüVRheinland ® . A customer feedback 

survey is given to all customers at the completion of 

their audit and is used to identify the following key 

points in providing good customer service: 

• Response time of services 

• Quality of services 

• Communications with staff 

• Technical competence 

• level of knowledge 

• level of courtesy 

• Overall impression 

• Professionalism of auditor 

If you are a quality customer, please take a few moments 

to respond to this mutually beneficial survey and qualify 

as the winner of TüVRheinland ® ’s monthly prize. Your 

satisfaction is important to us. Other response vehicles 

are available to TüVRheinland ® customers through an 

online feedback form available at www.us.tuv.com. 

For any certification, testing or compliance questions, 

please call 1-tUv-rheinlanD (1-888-743-4652). 


Announcing The Monthly Customer Feedback Survey Winners 

Management System Certification Response Yields Valuable Prize For 

Lucky Contestants 

1


Functional Safety Seminar 

hardware / software Design according to iec 61508 

target Group 

Developers, who are mainly engaged in the development 

of programmable electronic safety systems on the basis 

of the acknowledged international standard IEC 61508. 

This training imparts basic knowledge, which enables 

developers to transfer the requirements of the standard 

IEC 61508 most effectively. 

trainer 

Dipl.-Ing. heinz Gall is manager of the business sector 

“Automation, Software and Information Technology” of 

TüVRheinland ® Industries Service GmbH. His main tasks 

refer to consulting of design of safety concepts and the 

performance of trainings concerning topics of functional 

safety and safety engineering. 

Dipl.-Ing. Matthias Haynl is Business Field Manager of 

Functional Safety TüVRheinland ® north America. He 

has many years of experience - also internationally - as 

specialist concerning the area of functional safety of 

machinery and safety in the process industry. 

contents 

Introduction 

• Functional safety of electric, electronic and 

programmable systems 

Safety philosophy 

• Definition of risk, principle of risk reduction 

• Introduction to various classification systems (SK, SIl) 

• Comparison and relation of classification systems 

to each other 

International Standard IeC 61508 

• General methods and requirements 

• Consideration of life cycle aspects of safetyrelated 

systems and components 

• Requirements concerning management of 

Functional Safety 

• Requirements for the evaluation/judgment of 

Functional Safety 



• Definition of requirements according to the chosen SIl 

• Meaning of Safety Integrity level (SIl) 

• Consideration of faults and fault models 

- Fault: random fault, systematic fault, fault caused 

by handling, fault during operation 

- Fault models: stuck-at-, DC- and extended DCfault 

model 

• Definition of measures against faults 

- Fault avoidance 

- Fault detection and -control 

• Comparison “deterministic” and “probabilistic” 

method 

• Consideration during design-, development- and 

production phase 

- Safety requirement specification 

- Verification- and validation plan 

• Examples of 

- Hardware-design and verification 

- Software-design and verification 

• Calculation of the probability of failure on demand (PFD) 

- Derivation of Reliability Block Diagram for 

different systems 

- Derivation of formula for calculation of PFD 

- Architectural constraints, Safe Failure Fraction 

and diagnostic coverage 

- Interpretation of formula from IEC 61508-6 

- Influence of proof-test-interval, diagnostic-testinterval 

on probability figures 

- Redundant systems and common cause factor 

- Example for PFD calculation 

• Constraints and conditions for the phases 

- Commissioning, implementation, operation, 

maintenance 

- Operation 

1


Functional Safety Seminar 

hardware / software Design according to iec 61508 (continued) 

Application of safety-related Bus Systems 

• Application of standards IEC 61508, En 954, 

ISO13849-1 and En 50159 to the described methods 

and measures for bus systems. 

• Basic requirements for the application of bus-systems 

• Deterministic approach 

- Transmission error, random hardware failure, 

systematic failure 

Topic Overview 

agenda 

1st Day 

1. Introduction, overview of the TüV Functional 

Safety Program Day One 

2. Introduction into safety Introduction 

engineering 

3. Application The of the medical international device standard market landscape IEC 61508 

Part 1: General requirements and management of 

PAL 

functional safety 

The Japanese Pharmaceutical Affairs Law 


- Considerations of probability of transmission 

faults 

- Reliability of data transmission 

- Bit-failure rate 

- Failure-rate and failure-detection 

• Various Bus-Architectures 

• Examples for various bus-systems and safety 

considerations 

4th Day 

Summary of training - Questions and answers 

Speakers 

exam 

Duration approx. 3.5 – 4 hours 

Start: 11 am | End: approx. 3 pm 

Tamas 

Borsai 

the seminar will be held: 

2nd Day 

What PAL Means to You 

September 22-25, 2008 (4 days) 

1. Examples concerning management of functional Start: 9 am | End: approx. 4.30 pm 

Lunch 

safety 

Courtyard Boston natick 

2. Application Gaining access of the international to Turkey/Ukraine/Russia/India/ROW 

standard IEC 61508 

Title Here 

Loren impsom 

liab m pgobi 

p giua dpfio. 

Uhdpf ob dpf 

kdfpbj,dfgiab 

Part 2: Requirements of E/E/PES 

3. Determination and 

EU 

evaluation 

Regulatory 

of 

Update 

safety-related 

parameter (practical examples) 

MDD 

342 Speen Street mp gobi pgiu a dpfio uhdpf obd pf k 

natick, Massachusetts 01760 dfp bj, dfgiab mpg obip.pgobi pgiu a 

dpfio uhdpf . 

Phone: 1-508-655-6100 

Break 

3rd Day 

1. Determination and evaluation FDA Update of safety-related 

Fax: 1-508-655-6104 

cost: 

Michael 

Brousseau 

Title Here 

parameter (practical examples) 

2. Application of the international DAY standard 2 IEC 61508 

Part 3: Software requirements Introduction 

3. Practical example concerning part 3 

4. Requirements of Current tools State for configuration of IEC601 and 

parameterization of safety systems 

5. Requirements IEC of safety-related 60601 (2005) bus 3rdsystems Editionacc. 

$ 3,800.00 - Includes exam, training proceedings, Loren lunch impsom 

and refreshments 

liab m pgobi 

$ 3,400.00 - Without exam 

p giua dpfio. 

Uhdpf ob dpf 

kdfpbj,dfgiab mp- 

To register, please visit: gobi pgiu a dpfio uhdpf obd pf k dfp 

www.us.tuv.com or call bj, dfgiab mpg obip.pgobi pgiu. 

1-tUv-rheinlanD 

The to sweeping IEC 61508. new approach to medical regulatory compliance (1-888-743-4652) 

Lunch 

Richard 

Morroney 

Special guest 

IEC 60601 (2005) 3rd Edition 

from Clinivation 

Loren impsom 

1


TÜVRheinland ® Resources 

Assisting Your Company With Testing, Certification, 

Compliance & More 

Tradeshows 

To view other tradeshows that TüVRheinland ® will be visiting, please visit http://www.us.tuv.com/news/tradeshows.aspx. 

ieee emc 2008 

Cobo Center 

Detroit, MI 

August 18-22 | Booth #227 

iaei southwestern 2008 

International Association of Electrical Inspectors 

Monterey Marriott 

Monterey, CA 

September 7-11 | Booth #TBA 

imts 2008 

International Manufacturing Technology Show 

McCormick Place 

Chicago, Il 

September 8-13 | Booth #4795 

raps 2008 

Regulatory Affairs Professionals Society 

Hynes Convention Center 

Boston, MA 

September 14-17 | Booth #320 

iaei-northwest 2008 


Jantzen Beach Red lion Hotel on the River 

Portland, OR 


Seminars 

iaei- Western 2008 

international Association of Electrical Inspectors 

Best Western Ramkota Hotel 

Rapid City, SD 


international public transportation expo 2008 

San Diego Convention Center 

San Diego, CA 

October 6-8 | Booth #246 

pcb carolina 2008 

Raleigh Convention Center 

Raleigh, nC 

October 7 | Booth #TBA 

iaei southern 2008 


Hilton Alexandria Mark Center 

Alexandria, VA 

October 12-15 | Booth #TBA 

isa 2008 

Reliant Center 

Houston, TX 

October 14-16 | Booth #1244 

Please visit www.us.tuv.com/seminars for availability, cost and registration options. 

tUv functional safety program 

hardware/software Design according to iec 61508 

Boxborough, MA 

September 22-25, 2008 

(see page 14 for more details) 


ieee pses 2008 

Austin Marriott north 

Austin, TX 

October 20-22 | Booth #TBA 

pack expo 2008 


Chicago, Il 

november 9-13 | Booth #8316 

rsna 2008 

Radiological Society of north America 


Chicago, Il 

november 30-December 5 | Booth #7043 

1

market access JulY/08/aug 

TUV52-IT Ad-Monitor Head 7/3/08 11:01 AM Page 1 

For the absolute highest definition of product safety, trust TÜVRheinland. 

Marketing IT peripherals needs more than a price point; it 

needs a vision as well. A vision that's tempered by the kind 

of intelligence needed to prevent quality issues and production 

delays. Fact is, the category is so “commoditized” that 

there’s no room for recall-inducing and margin-reducing 

mistakes. That’s why it’s time to reboot your thinking and 

take advantage of our GRS program. Simply put, GRS 

stands for Global Retail Solutions, a customizable suite of 

QC, QA and compliance services so comprehensive they 

could only be offered by an industry leader like TÜV. If 

you’re tired of screening your testing facilities more carefully 

than you screen your production facilities, it's time you gave 

us a shot. See for yourself why we're a hit with anyone for 

whom the bottom line is top of mind. 

TÜVRheinland ® 

Precisely Right. 

call for a custom consultation: 

1-TÜV-Rheinland (1-888-743-4652) 

International: 1 (203) 426-0888 

© 2008 TÜVRheinland ® 

1


traci conroy • managing editor 

TüVRheinland ® 

12 Commerce Road, newtown, CT 06470 USA 

Tel 203-426-0888 

Fax 203-426-4009 

Email tconroy@us.tuv.com 

www.us.tuv.com 

Market Access is published six times a year by TüVRheinland ®. 

Subscriptions are free. This newsletter is published for the 

convenience of our customers, clients and professional 

associates. Although it is intended to provide accurate and 

authoritative information with respect to the subject matter 

covered, the information and opinions contained in this 

publication are those of the authors and not of the editor or 

publisher. The authors, editor and publisher disclaim any liability 

for any inaccuracies contained herein. Before any action is 

taken based upon the published information, it is essential that 

competent and individual professional advice is obtained. 

TÜVRheinland®, Inc. is an equal-opportunity/affirmative 

action employer. 

mission statement 

Employees and Leadership 

our employees are the most important success factor for the TÜVRheinland ® 

group. Their engagement, competence, neutrality and performance are key. 

Services and Products 

Demonstrable quality marks our services and products. This creates and 

secures competitive advantages. 

Technology and Safety 

We represent responsibly designed technology and set safety standard for 

the future. 

Customers and Markets 

Customers safeguard our existence. The customer must be convinced of the 

quality of our services in order for us to achieve success in the marketplace. 

Economic Success and a Secure Future 

Market-oriented thinking and efficient action secure the strength and 

independence of the TÜVRheinland ® group. 

Environment 

In our work, we demonstrate that environmental protection, technology and 

economics can be combined in a sustainable manner. This applies to both our 

services and our own product. 

The Public 

openness, competence, presence and neutrality as an independent third 

party determine our actions and shape our public image

market access market access JULY/08/AUG

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