New In Vitro Diagnostic Devices Regulation (IVDR)

There’s a new In Vitro Diagnostic Devices Regulation (IVDR) on the way, likely to be complete at the end of the year or the beginning of next.  Then of course, there will be a time lag as the text of the revised European Union (EU) regulation is prepared for distribution.  For those of you in the MedDev business, this and the new Medical Devices Regulation (MDR) will definitely have an impact.  Let’s take a look at some of the probable areas where you can expect change.

For the medical device industry, standards and regulations go hand in hand.  This is especially true in the EU since a number of regulatory requirements can be met with the use of compliance to specific standards.  So this major revision of these EU regs will require some changes to the way you do business.

First, you’ll want to know that it’s expected that the definition of IVD MD will be expanded to include any device that is a reagent, a reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended to be used in vitro.  This is for diagnosis (predisposition to a disease, possible reactions to a treatment, any collection of blood and/or other tissue samples).  You’ll only be exempt if your products are for laboratory or research use, plus 3 other special cases.

The proposed new IVD Reg includes a new supply chain regime and expands the Eudamed database (to be renamed the MDR Eudamed).  FYI:  The MDR Eudamed identifier number is intended to aligned with the FDA UDI numbering scheme.  It’s expected that there will be perhaps 25,000 European manufacturers in the database, as well as a similar number located outside the EU.  Not only will new records be added, but old records will be retained.

Other regulatory changes for IVD include a ‘lifestyle tests’ extension when working with the concepts of purposes and prediction.  Also, IVDs will be evaluated by the risk classes developed by GHTF (Global Harmonization Task Force) instead of the current list-based system.  Only Class A (low risk) will be exempt from conformity assessment by a notified body (NB).  This change in the risk assessment means changes in conformity assessment as well.  Many IVDs that can be self certified will now need to be certified by an NB.  Estimations put the change from 20% of IVDs now to 80% needing 3rd party certification when the regs come into effect.

Lastly, clinical performance studies will be required to support the CE mark under the updated IVDR as it is currently being proposed.  What does this mean for you?  Likely you’ll need to product significantly more clinical evidence.  You’ll need to be able to prove scientific validity, as regulations move to making you fully responsible for the clinical utility of your IVDs.

When will compliance with the revised In Vitro Diagnotistic Devices Regulation be mandatory?  Unlike the new MDR with it’s probable 3 year transition period, there may be a 5 year “grace” period for you to make the migration from the old regulations to the new.  And of course, should the new MDR Eudamed prove a failure, the regulations to implement it will not be enforceable.

If you’d like additional help in monitoring the new directives and obtaining the supporting standards as they are released, please get in touch with us.  Here at Document Center Inc. we support many medical device manufacturers.  We have a range of services as well as standard sales all geared to improve your compliance for the various certification schemes your product must comply with.  Use our webstore, www.document-center.com, for your purchases.  Or contact our staff by phone (650-591-7600) or email (info@document-center.com) for additional assistance.  Make us your Standards Experts!

21 CFR – the FDA Regs

21 CFR – Understanding the FDA Regulations

Every year the 21 CFR for the Food and Drug Regulations gets updated.  Yet many of you who use the Code of Federal Regulations don’t understand exactly what they are, how they work and how they are modified.  We know many of our customers must meet one or more of the requirements of the various parts.  So having a clear understanding of the process and content is essential.

The CFR system was developed as part  of the reduction of paperwork act.  It is a resource that compiles all regulations from each of the executive department in one place.  It’s a lot of information, so it’s updated on a yearly basis, with a publication cycle that releases approximately one-fourth of the titles each quarter.

For the 21 CFR, the resource for the regulations issued by the FDA, the annual date is April 1.  This means that each April 1st all the FDA regulations that are in force are handed over for publication as part of title 21.  However, it takes a bit of time to actually push the material through the publication cycle.  The pdf format copy is usually available relatively quickly.  The paper format copy is usually released 3 to 4 months after the cut-off date.

The 21 CFR contains FDA regulations separated by Parts.  Each part is a regulation on a specific topic.  So for example, 21CFR Part 11 is on electronic records and electronic signatures.  Part 820 is on quality systems.  Since the 21 CFR comes as a 9 volume set, you’ll need to know which part you’re looking for in order to get the volume that includes that material you need.

One common question is “How do I know if the part I use has been updated?”  Since the 21 CFR volumes are released on an annual basis, you don’t know the answer by looking at the publication date.  You need to have the new volume in order to check this out.  For your part, you’ll look section by section through the regulation.  At the end of each portion, there are a series of dates.

The first date at the end of each section tells you when the regulation was originally enacted.  Then additional dates monitor the issuing of any modifications to the original text of the reg.  Specifically, these dates all refer to the publishing of the material in the Federal Register.  If the last date on this list is less than a year old, there has been a change to your requirements.

Since regulations are updated constantly throughout the year, only publishing them in the CFR’s is not appropriate.  Indeed, there are other protocols that need to be met in order to provide for the kind of regulatory activity that is allowed by law.  The true vehicle for this is the Federal Register.

The Federal Register is used for a number of purposes.  First, it announces regulations that are being considered for implementation by any given department.  This allows for the necessary public comment period required by law.  Secondly, it is the official publication vehicle for the announcement of the adoption of any given regulation.  This can happen any time throughout the year.  And thirdly, agencies like the FDA use the Federal Register to announce workshops and other activities of interest to the general public.

Since all agencies use the Federal Register, it can be overwhelming to try to follow any specific piece of rule-making or the regulations released to enforce a particular piece of legislation.  This means that the CFR’s have a real role to play.  They give U.S. citizens a place to review this material by topic and source, not by date.

Of course, keeping up with an agency like the FDA is more complex that just following the 21 CFR’s each year.  You may have specific issues that can be helped by using the FDA Guidance Documents or other tools.  That’s why Document Center Inc. carries a wide variety of publications from many of the Federal Level agencies.

If you have questions about this, please get in touch with us.  Document Center has been working with government publications and a wide spectrum of standards since 1982.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  Our webstore is located at www.document-center.com.  We provide you with a resource for compliance documentation requirements and questions.  Make Document Center Inc. your Standards Experts!

AMS 5662, AMS 5663 and AMS 5666 – Nickel Alloy Specs

AMS 5662, AMS 5663 and AMS 5666 have all been updated!  The new revisions for these nickel alloy material specs are here now at Document Center Inc.  The specifications cover corrosion and heat-resistant nickel alloy in specified forms.  Each of the 3 new revisions stems from the usual SAE 5 year review.  Similar areas in each of these materials specifications are addressed in the updates.  Let’s take a look at each separately for a complete run-down of the changes.

AMS 5662, Revision N, “Nickel Alloy, Corrosion and Heat-Resistant, Bars, Forgings, and Rings 52.5Ni – 19Cr – 3.0Mo – 5.1Cb (Nb) – 0.90Ti – 0.50AI – 18Fe Consumable Electrode or Vacuum Induction Melted 1775 °F (968 °C) Solution Heat Treated, Precipitation-Hardenable.”

This type of nickel alloy (similar to UNS 07718) is used in applications where high resistance to creep and stress-rupture are required.  The alloy is often formed or welded prior to precipitation heat treating.   The following clauses have been modified:  Table 1 (composition), 3.3.1.3 (condition), 3.5 — Tables 2 and 3 (properteries) and 4.4 (reports).  Properties for product that have a diameter of 5 to 10 inches are added.  Conformance to AS-6279 in clause 4.4 is also added.

AMS 5663, Revision N, “Nickel Alloy, Corrosion and Heat-Resistant, Bars, Forgings, and Rings 52.5Ni – 19Cr – 3.0Mo – 5.1Cb (Nb) – 0.90Ti – 0.50Al – 18Fe Consumable Electrode or Vacuum Induction Melted 1775 °F (968 °C) Solution and Precipitation Heat Treated.”

Again, this type of nickel alloy is similar to UNS 07718.  It’s used for parts that need to be resistant to creep and stress-rupture as well.  Changes are to the same topics, but sometimes in clauses whose numbers differ from the AMS 5662.  So you’ll find changes to Composition (Table 1), Condition (3.3), Properties (3.5, Tables 2 aand 3) and Reports (4.4).  Additions are again, properies for product with a diameter of up to 10 inches and conformance to AS-6279 (in clause 3.8).

AMS 5666, Revision H, “Nickel Alloy, Corrosion and Heat-Resistant, Bars, Forgings, Extrusions, and Rings 62Ni – 21.5Cr – 9.0Mo – 3.65Cb (Nb) Annealed.”

As before, this nickel alloy specification has been updated due to the usual 5 year review.  The nickel in question can handle higher temperatures for both corrosion and oxidation resistance.  The material is similar in composition to UNS N06625.  Your updates will be found in the following sections:  Composistion (Table 1), Condition (3.2.1.1), Tensile properties (3.3.1.1 — Table 2), Grain size (3.3.1.3), Sampling and testing (4.3.1.1) and Reports (4.4).  Again, there is the addition of properties for product up to 10 inches in diameter.  And again, conformance to AS-6279 is added in clause 3.6.

For those of you who use these specifications (and many of you do!), these updates are a must.  Order them at the Document Center webstore, www.document-center.com.  Here’s a direct link for the order page for AMS 5662, for AMS 5663, and for AMS 5666.  Or you are welcome to contact our staff for assistance.  We can be reached by phone (650-591-7600) or email (info@document-center.com).

Some of you may remember that SAE standards used a DRM product that was difficult to install and use successfully.  You’ll be glad to know that the SAE standards from Document Center Inc. are no longer tethered to that product.  They are as easy to use as any of the other pdf format standards we carry.

And don’t forget — When you purchase these documents or any other standard from Document Center, you’ll get our best-in-class notification service free with your order.  It’s another reason to make us your Standards Experts!

Brexit and BS EN Standards

Now that we’re all getting used to the idea that the U.K. has voted to leave the European Union, what about the Brexit and BS EN Standards?  Does the Brexit affect Britian’s participation in CEN and CENELEC and the publishing of the BS EN documents?  Will BSI continue to act as a notified body?  Will it continue to be able to certify your organization’s products for sale within the EU?  Does this rejection of the regulatory burdens placed upon the U.K. by the EU affect British standards making?

For those of you who have referenced BS EN standards in your product documentation, you can breathe a sigh of relief.  While there will be some changes, the U.K. will remain within the CEN and CENELEC standards making process.  BSI should continue to adopt and distribute the BS EN standards.  And should their status as a notified body be withdrawn, they will surely find a notified body that they can represent in order to continue their certification activities.

How can this be?  Doesn’t the Brexit mean that the U.K. will not be a part of the European Union any longer?  Actually, there are several non-EU countries already participating in both CEN and CENELEC.  These include Iceland, Norway and Switzerland as well as candidate countries Macedonia and Turkey.  This is done by way of particiation in the European Free Trade Association (EFTA).  There is no suggestion as yet that the U.K. would pull out of this group.

There will be one notable result of leaving the EU for Britian:  It won’t be involved in the formal discussions in CEN and/or CENELEC on the needs of the EU with regards to any specific standard.  It will also be out of any discussions about mandates or decisions about harmonized standards.

So while Britians may be thinking that the Brexit vote will reduce the regulatory burden, this will be true only to a limited extent where goods and trade is concerned.  Part of the requirements that accompany national participation in CEN and CENELEC mandates adoption by a specific date.  They also dictate that duplicating or conflicting national standards be withdrawn by a specific date.  So while certain domestic regulation will again revert to the nation, much of the overhead of compliance with EU Directives and the Harmonized Standards system will remain.

Should you be concerned or want to use EN standards from an alternative European source, please get in touch with us.  Here at Document Center Inc. we have a number of options for you with regards to your EN standards.  Take a look by searching for standards at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

ISO 17468 – Food chain microbiology

ISO 17468, “Microbiology of the food chain – Technical requirements and guidance on establishment or revision of a standardized reference method,” has just been released.  It’s one of a number of new food chain microbiology standards issued by ISO during the last month.  This standard was developed in order to set up common rules for the validation of reference methods standardized in the field of food microbiology.

Keeping the food chain free from harmful organisms is an essential task for all food regulators and producers.  Failure results both in illness and even death but also in extraordinary expense and loss of public trust.  Therefore, those of you regulating or providing products intended for human consumption and/or animal feed need to be particularly vigilant.  This means the use of sampling and other test methods to assure the quality of goods within the pipeline.

Setting up a program that can reliably identify various microorganisms as early as possible is essential.  But what tests to use and when?  This is where standards developers come in.  Since the globalization of our food sourcing has become commonplace, a need for international standards for testing various materials for a wide variety of micro-organisms has been established.

ISO 17468 provides a guideline on how to evaluate a potential new test in order to set the stage for standardization of the process.  It establishes a series of steps necessary for technical verification of a new reference method.  These steps include not only the selection of the possible test but the studies required to support the case for standardization.  These include evaluation, multilaboratory, validation and interlaboratory studies.  A flowchart is included in Annex A.

Supporting this work are two new standards that are referenced in the ISO 17468.  They are ISO 16140-1, “Microbiology of the food chain – Method validation – Part 1: Vocabulary,” and ISO 16140-2, “Microbiology of the food chain – Method validation – Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method.”  As you can see, ISO/TC 34/SC 9’s working group 6 for microbiology of the food chain has been hard at work setting up the structure for further standardization.

If you’re tasked with standardizing or regulating identification of hazards in the food chain or have products that are impacted by this work, you may want to get a copy of this new ISO standard or the companion documents.  Document Center Inc. is an authorized distributor of the ISO standards and you can search for and order them at our webstore, www.document-center.com.  Here’s a direct link to the order page for  ISO 17468 for your convenience.

Have further questions or need personalized assistance?  Just contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards since 1982 and recognize that there’s more to standardization than just the transaction.  So our staff can provide you with knowledgeable support.  And we have a wide range of supporting services as well.  Our notification service is best-in-class.  Make us your Standards Experts!

SNT TC 1A 2016 Edition is here!

SNT TC 1A, “Personnel Qualification and Certification in Nondestructive Testing,” has just been updated.  The new 2016 Edition is available from Document Center Inc. now.  The recommended practice comes with the new 2016 Edition of the CP 105, “ASNT Standard Topical Outlines for Qualification of Nondestructive Testing Personnel.”  The SNT TC 1A is usually released on a 5 year review cycle and was last updated in 2011.

What is the SNT TC 1A?  This is a guideline for employers who have or are implementing an in-house program to certify NDT (nondestructive testing) staff.  It sets up 3 levels of qualification based on education, training, experience, and exams.  You’ll use this information to manage your training, qualification and certification program for NDT personnel.

How long has the SNT TC 1A been used?  The recommended practice was first released in 1966.  While there are other programs available, this is the most popular.  Certainly here at Document Center, we find that many of our customers use this publication.

Are there other tools to help me set up my program?  Yes, ASNT has a number of related publications.  These include the “A Guide to Developing NDT Certification Examinations.”   However, the bulk of these companion documents are still at the 2011 Edition levels, which mean that the changes in the new 2016 SNT TC 1A have not been integrated into them yet.

How can you get a copy of the SNT TC 1A?  Try using Document Center Inc.  You can search for and order standards at our webstore, www.document-center.com.  Here’s a direct link to the order page for SNT TC 1A for your convenience.  You’ll get our best-in-class notification service free with your purchase.  This means you’ll get an email notification each time the publication is revised in the future.

Have more questions about this or any other standard?  Want to discuss your order before you place it?  Just get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards since 1982 and have a wide knowledge of standards and the organizations that publish them.  Make us your Standards Experts!

 

ASTM D4169

ASTM D4169 2016, “Standard Practice for Performance Testing of Shipping Containers and Systems,” has just been released.  I’ve posted about this standard before, since it is widely used by many companies to make sure shipping containers can protect the goods they contain.  The standard provides a list of hazards to which shipping units might be subjected.  It then show you how to set a test plan with tests for confirming the ability of containers to withstand specific challenges.

It’s a lengthy standard for ASTM, some 17 pages long.  It was previously revised in 2014, however that edition has been replaced by the new ASTM D4169 2016 Edition.  Details of the changes are of course spelled out for you in the redline edition, available from Document Center Inc. should you like.  However, the authoring committee does list that you’ll find these changes in the following clauses:

  • 12.1, 12.3, 12.4, and 12.4.1 (revised)
  • 12.4.1.1, 12.4.1.2, 12.4.1.3, 12.4.1.4, 12.4.2, 12.4.2.1, 12.4.2.1(1), 12.4.2.1(2), 12.4.2.1(3), and 12.4.2.2 (added)
  • Table 2, Table 3, and Table 4 (added)
  • Note 4 (added)

FYI: There are additional areas in the redline edition that are marked with black lines in the margin.  These can be found in both the body of the document and in the Annexes (mandatory) and Appendices (informational).

You’ll notice that most of the changes occur in Section 12, information on Schedule D and Schedule E (stacked vibration and vehicle vibration respectively).  These schedules are used when setting up your test plan sequence.  The tests are arranged in a certain sequence based on a time-line of expected hazards.  The schedules provide you with a set of tests for the types of hazards that might be encountered at each stage of the time-line.

Now to get your copy of the new Edition.  Order online at the Document Center Inc. webstore, www.document-center.com.  We’re an authorized ASTM distributor, in business since 1982.  Here’s a link to the order page for the ASTM D4169 for your convenience.  If you have additional questions or want the redline edition, just get in touch with our staff.  You can reach them by phone (650-591-7600) or by email (info@document-center.com).  Make us your Standards Experts!

 

STD 595 Color Chips — They’re back!

The STD 595 Color Chips are back!  Ever since SAE took over the responsibility for the FED STD 595 “Colors Used in Government Procurement” (republishing it as AMS STD 595), there has been no authorized source for the color chips so many of you use.  The wait is over!  SAE has just issued official copies of the chips in 3 formats.  These are the complete set of 3X5 chips, the fandeck format, and individual chip sales.

Why did SAE take over the publication of the FED STD 595?  Ever since the mid-1990’s, the federal government (and in particular the DoD) has been mandated to look for commercial sources for the documentation used in the procurement process whenever possible.  Moving the FED STD 595 to SAE with the publication of the AMS STD 595 meant that the GSA (General Services Administration) could shed the responsibility for maintaining this challenging chip set. The only problem was that SAE was not fully prepared for the transfer.

Why were the color chips missing from the AMS STD 595 when it was released?  At first, SAE just published the text component of the standard.  The contents include methods for calculating compliance without the use of the color chips.  However, industry relies on the color chips far more than expected.  So it looks like SAE had to go back to the drawing board to get a source of supply for the chips that would comply with the exacting requirements.

How can you get these new chips?  As an authorized SAE distributor, Document Center is here for your AMS documentation requirements, including the STD 595 color chips!  Go ahead and order them at our webstore, www.document-center.com.  Here’s the direct link to the order page for the STD 595 complete set of chips and the order page for the STD 595 Fandeck.  Individual chips may also be supplied.

Have more questions?  Please get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been supplying specs and standards to government contractors since 1982.  We’re a trusted source for all your compliance requirements.  Make us your Standards Experts!

ISO TS 16975-1 – Respiratory Protection Device Programs

ISO TS 16975-1, “Respiratory protective devices – Selection, use and maintenance – Part 1: Establishing and implementing a respiratory protective device programme,” has just been released.  This new Technical Specification and it’s companion specification ISO TS 16975-2 help you determine when there’s a risk of the presence of a hazardous atmosphere and choose the correct respiratory protection device (RPD) for your situation.  It is geared towards helping employers establish and implement a safety program for the use of these devices.  It contains information on risk assessment, the process for selection, training, use and maintenance.

The use of RPDs can prevent injury, illness or death.  With such risks associated with hazardous atmospheres, select and use of these devices can be critical.  Using this technical specification and it’s companion can help anyone responsible for the use of these products to make sure that all risks are being adequately addressed.

Your ISO TS 16975-1 covers situations for using RPDs, information on an RPD program, and risk assessment for making your RPD selection.  This includes flow charts to help you with your selection procedure, training, and maintenance and storage.    Even records and record-keeping are addressed.  However, a major portion of the publication is devoted to eleven informative Annexes, all packed with practical information for you to use.

Some topics found in this Annex section are the types and components of RPDs, hazard assessment, suitability assessment, compressed air pressures for RPDs, classification overview, and an example of a selection record form.  A 12-item bibliography completes the document.

If you’re in a small or medium-sized enterprise, you may want to take a look at the ISO TS 16975-2 as well.  It’s a “condensed guide” for establishing and implementing a RPD program.  Here you’ll find basic information on risk assessment, selection procedures, training, use, and maintenance.  Guidance is enhanced by the use of a table format as a review of the selection process.  It provides you with a step-by-step approach to your RPD decision making challenges.

Now you’ll need a copy of one or both of these ISO standards.  Document Center Inc. is an authorized distributor of these publications, so search for and order standards at our webstore, www.document-center.com.  Here’s a link to the order page for ISO TS 16975-1 and the order page for ISO TS 16975-2 for your convenience.  They’re available for purchase in either paper format or for pdf download.

Other order options and more information is available from our staff.  Get in touch with us by phone (650-591-7600) or email (info@document-center.com).  We can assist you with a wide variety of standards questions and requirements.  Make us your Standards Experts!

MIL-PRF-55110 New Amendment 1 for Revision H

MIL-PRF-55110, “Printed Wiring Board, Rigid, General Specification for,” has just been updated and the new Revision H with Amendment 1 interfiled is available now from Document Center Inc.  Formerly known as MIL-P-55110, this specification has been an essential PWB document for quite some time.  However, ever since the end of 1997, it is only used for replacement purposes.  For new design, be sure to use MIL-PRF-31032.

There has been quite a bit of updating lately for our standards and specs on Printed Wiring/Circuit Boards.  The IPC-A-600, IPC-A-610, and J-STD-001 have all be revised as well.  The MIL-PRF-55110 complements these other  publications by addressing U.S. government requirements used during the procurement cycle.  It is a performance specification, defining qualification requirements for rigid single-sided, double-sided, and multilayered printed wiring boards.  These boards may or may not be plated through holes.  Detailed requirements may be further specified in referenced drawings and other documentation.

Those of you using the MIL-PRF-55110 will want to know where the changes instituted by the Amendment 1 will be found.  For your convenience, black lines have been inserted into the margins where the changes occur.  New references are made to the Qualified Products Database 55110, a change in how the QML or QPL information is made available to government contractors.  There’s also an administrative update to how CAGE code information is provided.

Technical changes occur in Annex A sections A.3.5, A.3.5.1, A.3.5.5.1, A.3.6.1, A.3.6.2.1.1, A.3.6.2.1.2, Table A-III, A.3.6.4.5, A.3.7.4.6.2, A.3.7.6.2.1.2, A.4.5.1, A.4.6.2.2, Table A-VI, A.4.7, A.4.7.1.1, A.4.8.2.1, and A.7.3.  In Annex D, look for changes in section D.4.2.  In Annex F there’s a change in Figure F-4’s notes.  Figure G-22 has been revised in Annex G.  For Annex H, Table H-I has been updated.  As always, the document does note that all changes may not have been marked so it is your responsibility to make sure you meet all it’s requirements.

When will you need to comply with MIL-PRF-55110 Revision H and Amendment 1?  You’ll have until September 20, 2016 to meet the updated requirements made by the amendment.

Where can you get a copy of this 134-page interfiled specification?  Try using Document Center Inc.  We can get you a copy promptly and have the best-in-class notification service to help ensure that you are always aware of changes to any standard you purchase from us.  Search for and order specs and standards at our webstore, www.document-center.com.  Here’s the direct link to the order page for MIL-PRF-55110 for your convenience.

Need an enterprise solution for your company, a portal where your employees can access your compliance standards 24/7/365?  Ask our staff about our Standards Online service.  This is a system you can tailor to meet the needs of your organization when it comes to having essential documentation available anywhere, anytime.  Check in with our staff for more information.  You can reach them by phone (650-591-7600) or email (info@document-center.com).  We’re a woman-owned business, established in 1982, here to help you with your standardization concerns.  Make us your Standards Experts!