Archive for the ‘Hot Topics in Standardization’ Category

« Older Entries

How do I find Standards for exporting medical devices to Europe?

Wednesday, February 20th, 2013

Many times folks like you come to Document Center when they are unsure what standards are applicable for exporting their products overseas.  And this is especially true during the certification process for exporting medical devices into the European market.  Here at Document Center, we have a number of ways to help you out.  And the easiest is to use our webpage of Harmonized Standards based on the European Directives (comparable to our federal regulations).

These lists are actually generated by the EU (European Union) itself, under what is called the “New Approach.”  This is a way to achieve compliance to a directive by an EU member nation through the mechanism of standardization.

There are three main directives for the medical device industry.  Luckily, for each of these directives there is a list of harmonized standards that meet the requirements of the legislative act.  Here’s the information on the directive and a link to our page of harmonized standards for each:

You’ll notice that the list specifies the documents only as EN (European Norm or European Standard) documents.  However, when you click the link for each item, you see the record to purchase a BS EN document.  The reason for this is that the EN documents are not released as stand-alone items, but always as republications as adopted by each European Union nation.

The BS EN copies are the official English Language editions for each EN document.  However, any EN copy in English will be the same — only the national cover sheet administration information will change, depending on what country you purchase your copy from.

Something else to be aware of is the fact that when the EU adopts an international standard (like an ISO standard), it may include European administrative information about the source material.  This is usually in the form of Annexes which cover how the adopted standard meets or fails to meet the requirements of the Directive it supports.  For this reason, you may wish to purchase EN editions of International standards, even though the source International standard will not be modified by the adoption.

These lists do change periodically, so you may want to book-mark our pages and visit them every 3 to 6 months for a quick review…

Use Document Center’s website at www.document-center.com to find but and purchase the standards you need for regulatory compliance.  Or you may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for additional information or to place your order.  We are here to provide you with the standards support you need in order to manage your documentation requirements successfully.

Tags: , , , , , , , , ,
Posted in Hot Topics in Standardization | No Comments »

Yesterday’s Executive Order on Cyber Security to impact U.S. Standards Development

Wednesday, February 13th, 2013

President Obama’s February 12th Executive Order, Improving Critical Infrastructure Cybersecurity, is definitely going to impact the standards community.  In it, the President specifically states “It is the policy of the United States to enhance the security and resilience of the Nation’s critical infrastructure and to maintain a cyber environment that encourages efficiency, innovation, and economic prosperity while promoting safety, security, business confidentiality, privacy, and civil liberties. We can achieve these goals through a partnership with the owners and operators of critical infrastructure to improve cybersecurity information sharing and collaboratively develop and implement risk-based standards.”

First steps include the development of methodologies for identifying specific threats and providing unclassified government reports that can be widely shared with industry.  In the classified arena, the Defense Industrial Base pilot will be renamed and expanded as the Enhanced Cybersecurity Services program, for companies and individuals with security clearances.

NIST (the National Institute of Standards and Technology) will spearhead the development of a Cybersecurity Framework.  This framework will include a set of standards, methodologies, procedures, and processes to address cyber risks.

NIST has been playing an active role in recent years in bringing together regulators and industry standards developers in order to align the interests of government with the resources and infrastructure development provided by U.S. industry associations.

As far as industry is concerned, organizations to watch include:

  • the Internet Security Alliance, a consortium focused on developing policy and providing advocacy
  • ANSI (the American National Standards Institute), spearheading a joint standards-development strategy
  • IEEE, working on standards in the area of electric utility control systems
  • ISA (International Society of Automation), providing standards on computerized control system security
  • ISO/IEC JTC1 (Joint Technical Committee 1), developing security management systems at the international level
  • IETF (Internet Engineering Task Force), the fundamental Internet standards developer
  • ITU T Study Group 17, develops Recommendations on Cybersecurity

You should also be aware that since 9/11, one notable area of joint effort has been the ANSI Homeland Security Standards Panel.  This forum for the co-ordination of standards development between ANSI accredited standards developers and the Department of Homeland Security is sure to be a part of this new cybersecurity effort.

Congress has been working on a similar piece of legislation, Cyber Information Sharing & Protection Act (CISPA), which so far hasn’t managed be passed.  This is another reporting effort, this time providing for information sharing between private companies and the government about cyber threats.  The executive order only provides for information sharing from government to industry, lessening concerns about the transmittal of private information without permission.

You can expect that, as with healthcare information, when the government decides to set a firm course on how it will secure and exchange this type of information, there is a great deal of opportunity for the players in this space.  And the final results will impact our information infrastructure far beyond the scope of work as currently defined.

Find out more about Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re in the business of standards and are here to assist you with any and all questions and requirements you may have.

Tags: , , ,
Posted in Hot Topics in Standardization | No Comments »

Document Center’s 20 Top Selling Standards of 2012

Wednesday, February 6th, 2013

Yes, it’s time to review Document Center‘s top selling standards of 2012.  Do you use any of these popular items?

  1. BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
  2. BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
  3. ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
  4. BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
  5. ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
  6. AMS 2750, New Revision E, Pyrometry
  7. 21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
  8. ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
  9. SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
  10. IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  11. MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
  12. ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
  13. ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
  14. ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
  15. IPC-A-610, Revision E, Acceptability of Electronic Assemblies
  16. ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
  17. ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
  18. ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
  19. ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
  20. IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies  – tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

Tags: , , , , , , , , , , , , , , , , , , , ,
Posted in Hot Topics in Standardization | No Comments »

Did you know Document Center’s Quarterly Standards Reporter can solve your documentation auditing problems?

Wednesday, January 23rd, 2013

For many of Document Center’s customers, the issue of keeping their compliance collections in good condition for the various quality and regulatory audits they face is an on-going issue.  Our quarterly Standards Reporter service is one way companies like yours have solved this problem.

This report is tailored for folks who have identified the standards and regulatory documents they need to maintain in order to pass their regular reviews (and keep their companies documentation in good order for the sake of providing their customer base with a reliable and safe product).

Working with Document Center, these customers have made sure that all applicable documents are on our notification service.  Then, once a quarter a report is generated that lists all those standards in our system.  It is provided to the customer both in paper and excel spreadsheet format.

The report itself is a listing of all the standards, titles, and the current revision levels, including the release date.  Any current document components like amendments, correction sheets, and so on are included.

We’ve got one customer who has relied on this service for years, and has even written it into the company’s quality protocols for his documentation requirements!

If you need a way to easily verify your methodology for reviewing your documents on a regular basis to assure your company and your compliance auditors that your documentation is current, consider Document Center’s quarterly Standards Reporter service.  For the low annual fee of $120.00, you too can cross another area of potential liability off your list.

More information on Document Center Inc. can be found on our website, www.document-center.com.  To order the service, contact our sales staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll be happy to provide you with all the information you need to get started on our collection maintenance program.

Posted in Hot Topics in Standardization, Standards Document Control | No Comments »

ROHS I replaced by ROHS II (2011/65/EU) this month — Restriction of Hazardous Substances Directive

Friday, January 18th, 2013

For those of you interested in lead-free electrical and electronic equipment, there’s a big change happening in Europe this month.  ROHS I (2002/95/EC) has been replaced by ROHS II,  ”Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast).”

There’s no change to the list of the six controlled substances banned under ROHS I.  However, a review of Annex II (the list of restricted substances) must be done by the Commission by 22 July 2014, using a procedure based on the restriction process of the REACH Chemicals Regulation (Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals).

Also the scope of the directive has been expanded with the release of ROHS II.  Covered Electrical and Electronic Equipment (EEE) now includes products dependent on electric current or electromagnetic fields for at least one intended function.  ROHS I only applied to equipment that depended on electric current or electromagnetic fields for its primary function.

RoHS II also added three new categories of EEE: medical devices, monitoring and control equipment, and “all EEE not covered by any other category.” Medical devices and monitoring and control equipment are included as of 2013. The broader “other category” does not apply until 2019. This will include any electrical and electronic product that is not specifically excluded.

FYI: Permanent exclusions from RoHS include the following: military equipment, space equipment, equipment designed to be part of another piece of equipment falling outside the scope of RoHS, large scale industrial tools, large scale fixed installations, means of transport for persons or goods, non road mobile machinery, active implantable medical devices, photovoltaic panels, equipment for research and development only available business to business.

The exemptions process in ROHS II has been amended as well.  Now there are three categories of exemptions: exemptions for technical applications of all categories of EEE, exemptions for medical devices, and exemptions for monitoring and control instruments. The 4-year review process has been abolished, so companies must request an exemption renewal 18 months before expiry. All exemptions (except for those applying to medical devices and monitoring and control instruments) are subject to a 5 year time limit. And there are new exemption criteria including the availability and reliability of substitutes and socio-economic impact.

If you need help with obtaining European Directives or with the harmonized standards developed for compliance, please use Document Center’s website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We handle regulatory material as well as industry and government specifications and standards.

Tags: , , , , , , ,
Posted in Hot Docs - New Standard Releases, Hot Topics in Standardization | No Comments »

What did happen at the ITU meetings in Dubai???

Friday, December 21st, 2012

As a follow-up to an earlier post this month, we’ll revisit the WCIT 2012 meetings in Dubai and try to determine what exactly happened there.  Now that the ITU (International Telecommunications Union) meetings are over it seems there are two opposing views on the event.  One is the official version of consensus and success, the other is the sigh of relief by Internet organizations that a bullet has been dodged.

Of course, the truth lies somewhere in between.  Yes, the meeting did result in a new Treaty being adopted.  Yes, the fact that many countries will not sign the Treaty means that it will be unenforceable.

So what is the take-away?  First I think the most interesting aspect of this whole tempest is the light that was shed on the way International organizations conduct business.  For those who have never been involved in politics at this level, trying to participate in and understand the event proved challenging and enlightening.  Standards folks often believe that standards represent the triumph of reason.  International forums prove that standards are a result of a political process and you’re best not to forget it!

Secondly,  the meetings highlight the fact that nations have a stake in the Internet and are searching for ways to assert control over the wires used to transport all those packets, even as they’ve traditionally controlled telegraph and telephone lines.  ITU has historically done much good in the world by harmonizing the way your phone, fax, and Western Union wires work everywhere you need to communicate.  It is not surprising that ITU is the first battleground for inserting national interests into the protocols used by the Internet.

Third, the meeting highlights the strong resolve of the United States, the European Union, and others to support the current Internet system.  Of course, the flip side of this is we’re now aware of the desire of Russia, China, Arab and African countries to find a means to generate tax revenue and promote censorship under an Internationally sanctioned agreement.

Will this divide in outlook crop up again?  Most assuredly so.  We can consider Dubai to be yet another salvo in an on-going battle to define the Internet and how the Internet is controlled.  Congratulations to interested Techies in helping to bring a little sunshine into the process and help us all understand how this particular venue a bit more.

From our earliest days on the Internet in 1993, it has been clear that there are competing interests all looking to dominate this new communications tool.  Whether it’s the demands of business or government, someone is always looking for a way to dominate the media and change how you use this new environment.  I have always hoped for the continued success of the technical experts who were the first Internet standards developers.  But which side won this time?

Document Center Inc. provides standards and standards management support.  Purchase standards at our webstore, www.document-center.com.  Or contact us by phone (650-591-7617), fax (650-591-7617) or email (info@document-center.com) for more information on how we can help you.

Tags: , , , ,
Posted in Hot Topics in Standardization | No Comments »

Controversy surrounds ITU’s 2012 World Conference on International Telecommunications

Tuesday, December 4th, 2012

ITU (the International Telecommunications Union, a UN organization) is holding meetings in Dubai and the swirl of controversy surrounds the World Conference on International Telecommunications (WCIT-12) meetings that began today.  WCIT-12, a global treaty conference, is set to review the International Telecommunication Regulations (ITRs), which were last addressed at the World Administrative Telegraph and Telephone Conference in Melbourne, Australia, in 1988.

Prior to today’s  opening ceremonies, the usual World Telecommunication Standardization Assembly (WTSA) was held last week.  This meeting occurs every four years and defines the next period of study for ITU-T.  Current new focus areas include expanding ITU standards on e-health, software-defined networking (SDN) and e-waste.  Noteably, there was also a Resolution inviting ITU Member States to refrain from taking any unilateral and/or discriminatory actions that could impede access to the Internet.

Which bring us to the WCIT and the issue that is causing a stir in the IT community — is ITU planning to try to usurp control of the Internet?  As part of the opening ceremonies, Fadi Chehadé, president of ICANN (the Internet Corporation for Assigned Names and Numbers) proclaimed a new season of  cooperation between ICANN and ITU.  Addressing today’s “historic opening ceremony,” Chehadé said  “I am here because I believe in the power of engagement. Engagement starts with listening.”

In spite of all assurances to the contrary, many Internet companies and interested parties are concerned that this is yet another attack on governance of the Internet.  With many years of an open and technology-based system, folks are not enthused about seeing control move to an organization that is composed of nations, with monitoring and censorship goals in stark opposition to the current open system.

Not only is there talk of the ITU taking over the responsibilities of ICANN (assigning Internet numbering, addressing and identification services), but also the possibility that ITU member nations might be allowed to tax Internet content companies for transmitting data across national boundaries.  Such proposals are coming from Russia, Africa, and the Middle East, areas where the internet is having a profound impact on society.

ITU started out as the International Telegraph Union back in 1865 and then was renamed the International Telecommunications Union in 1932.  Due to the technical basis of it’s work, ITU has been in the forefront of International Standardization and creating standards in advance of implementation for many years.  However, in this case, the Internet has been developed and shaped independently, leaving ITU behind as new systems for standards development have been created by the Internet Society and it’s IETF (Internet Engineering Task Force), IAB (Internet Architecture Board), and IRTF (Internet Research Task Force).

We’ll be watching to see what developments occur as the WCIT continues for the next two weeks.  But for more information as the conference progresses, see the Internet Society webpage on this meeting.

Document Center Inc. provides standards sales on its website, www.document-center.com.  We also monitor and audit standards collections for our clients.  For more information, please contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been in the standards business for 30 years and can assist you with all your standards requirements.

Tags: , , , , , ,
Posted in Hot Topics in Standardization | No Comments »

ANSI Z87.1 2010 Edition – The standard for eye and face protection in the workplace

Thursday, November 29th, 2012

When it comes to best selling standards, ANSI Z87.1, “Occupational and Educational Personal Eye and Face Protection Devices,” is near the top of Document Center‘s list.  The reason why?  In the world of personal protective equipment (PPE), it’s the go-to standard for eye and face protection here in the U.S.

This standard provides guidance on general requirements, testing, permanent marking, selection, care, and use of protectors.  The 2010 revision adds specific performance and marking requirements for devices claiming to provide protection from splash/droplet, dust or fine dust hazards that were not included before.

The intent of this document is to minimize the occurrence and severity or prevention of injuries from such hazards as impact, non-ionizing radiation and chemical exposures in occupational and educational environments, as may be found during machinery operations, material welding and cutting, chemical handling, and assembly operations.

ANSI Z87.1-2010 helps users define selection of the appropriate eye and face protective devices based on the hazard.  And to help with compliance, the 2010 edition describes two levels of protection: “Non Impact Rated” and “Impact Rated.”  Further, the standard adopts the European (CE) small and medium head sizes so testing can harmonize with international test methods.

Of course, certain hazardous exposures are not covered in this standard. These include bloodborne pathogens, X-rays, high energy particulate radiation, microwaves, radio-frequency radiation lasers, masers, and sports and recreation.

ANSI standards can be purchased from Document Center Inc. at our webstore, www.document-center.com.  Many are available in both paper and pdf format.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Not only do we accept credit cards, but for U.S. organizations we accept purchase orders conforming to our net 30 terms.  We have been selling standards and providing support services to our customers for 30 years.  We’d like to add you to our list!

Tags: , , ,
Posted in Hot Topics in Standardization, Top Selling Standards | No Comments »

Giants win the World Series – But did the champagne goggles meet the ASTM F803 standard?

Monday, October 29th, 2012

Yes, all of the San Francisco Bay Area is cheering for the rousing 4 game sweep of the World Series by the Giants!  My husband and I are big fans and enjoyed the entire Sunday evening broadcast, laughing at the wild scene in the dugout after the game was won.  However, my husband did notice one thing — the eyewear that the players were wearing while spraying champagne on each other were genuine Major League baseball goggles!

So that begs the question, did standards play a role in this event?  Checking it out this morning, I have to suspect that the goggles were made using the ASTM F803, “Standard Specification for Eye Protectors For Selected Sports.”  Protective eyewear made according to this specification offers protection only to the eyes and does not protect other parts of the head.  To my untrained eye, it looked like the goggles would meet the requirements of Type I, a protector with the lens or lenses and frame frontpiece molded as one unit.  In this case the frame temples or other devices, such as straps, to affix the lens may be separate pieces.

That leaves us with just one other pressing standards question:  Did the brooms in the stands being waved in honor of the sweep meet ASTM F2367, “Standard Specification for Labeling for Upright Brooms for Consumer and Institutional Use?”

Hope you had a great weekend and that you’re safe and sound if you’re in the wild weather hitting the East Coast!

We’ll be open all week, so please order the standards you need from us at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll be here at Document Center Inc. to help you with your standards needs and questions.

Tags: , , , , ,
Posted in Hot Topics in Standardization | No Comments »

Why can’t I find a standard referenced in the Code of Federal Regulations?

Wednesday, October 24th, 2012

In the on-going discussion about standards that are incorporated into regulations by reference (via the Code of  Federal Regulations or CFRs), one common problem has not been getting the attention that it needs.  Here at Document Center Inc. we had two customers approach us today with the same basic problem — Standards referenced in the CFR regulations that each needed are so old that they’re no longer available for purchase.

How can this happen?  It’s actually quite simple.  The first step is the complexity of getting an external document into our regulations.  Here, the intention is good.  Why create U.S. regulations for topics that are already adequately resolved by external industry standards?

Yet, in order to get a publication into the CFR, there is a process that requires the reference to be to a physical document that is in existence at the time of adoption.  So, when a standard is included in our regulations, it is adopted not only with the standard number, but also the year of the publication.  And here is where the trouble begins.

As time goes by, our regulator looks at his work and at the standards he’s referencing.  Yes, they may be periodically updated, but the changes aren’t affecting his regulation.  Why go through the laborious process of referencing a new revision of the standard when the edition in the regulation is still working?

But for the person wanting to meet the requirements of the regulations, each revision update that occurs in the industry standard but not in the CFR reference means an increased chance that the document is out-of-print and no longer publicly available.  And suddenly, the system that is working smoothly for the regulator becomes impossible for those who are being regulated.

Why do I bring this up now?  Certainly, the federal government is aware that there are issues involved in the process of the adoption by reference system currently in place.  And that’s good, because it’s impossible to comply with regulations calling out standards like the ANSI B7.1 1970 Edition (or 1964 Edition) and the ASME B56.1 1959 Edition.  You just can’t get those documents any more!

When you have standards questions or need obsolete editions of documents, please get in touch with us here at Document Center Inc. (www.document-center.com).  We do have an extensive collection of out-of-date standards.  And we have the expertise to help you with the complex questions the other guys don’t have time to answer.  Just contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards for 30 years and can assist you with all your requirements.

Tags: , ,
Posted in Hot Topics in Standardization | No Comments »

« Older Entries