New AAMI TIR34 – Water for reprocessing Medical Devices

October 10th, 2014

AAMI, the Association for the Advancement of Medical Devices, has two main roles in standardization here in the U.S.  First, it acts as the Technical Advisory Group (TAG) for medical device standardization at the international level.  And secondly, it provides guidance for U.S. companies when international standardization has not yet taken place.  One of these AAMI Technical Reports, AAMI TIR34, has just been updated.  Document Center has the new 2014 Edition now so you can purchase it in paper format or for pdf download.

Titled “Water for the reprocessing of medical devices,” AAMI TIR34 covers the complete range of issues involved in what is basically sterilization of medical devices using water.  You’ll learn why water quality is important, the categories of both medical devices and of water for the reprocessing function, what types of water treatment you’ll need to consider, and the stages of medical device reprocessing where water quality is a factor.

Of course, in order to set up an effective water treatment process you’ll need to know about the various water treatment systems available and what will work best in your situation.  The standard covers this, down to the issues of the physical layout of the water purification system to distribution and storage.  You’ll also get complete guidance on how to monitor the water quality in your system, both in clause 7 and in Annex B.  Concluding sections cover strategies for bacterial control, personnel considerations, and quality concerns.

You’ll also be pleased to know that there are 7 Annexes that review the various issues in detail — from the monitoring issues noted above to thermal disinfection, water treatment using filtration and the typical presentation of quality issues during reprocessing.

What’s new in this edition?  Of course, there are many updates and organization enhancements throughout the document.  But the committee also brings the fact that the water categories have been reduced to two from the previous four that were specified in the 2007 Edition.

How do you get a copy?  Due to copyright considerations, you’ll want to make sure you purchase your copy from an authorized dealer.  Document Center Inc. is such a source.  You can order any standards you need at our web store, www.document-center.com.  Or feel free to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Interested in multi-user online subscription access?  We have that too!  Remember, Document Center has been providing standards to folks like you since 1982.  Make us your Standards Experts!

ISO 22400-1 released – KPI’s for Manufacturing

October 9th, 2014

Key Performance Indicators (KPIs) are a valuable tool for the management of manufacturing operations.  By choosing a few measurements, and perhaps manipulating them into monitoring values, an organization can better realize it’s objectives.  The ISO 22400 series has been developed on this very topic and the Part 1, ISO 22400-1, has just been released.  Titled “Automation systems and integration — Key performance indicators (KPIs) for manufacturing operations management — Part 1: Overview, concepts and terminology,” it’s a great introduction to KPI and the value it brings to any business.

The ISO 22400-1 was specifically developed for MOM (Manufacturing Operations Management).  The KPI’s generated will be from data from the control domain with an eye to providing decision support information.  However, you’ll find it a relevant document if you need to understand the concepts and data flows used for generating and using KPI’s in general.

The beginning of the standard is fairly routine, with a scope clause, then terms and definitions, as well as an abbreviated terms section that’s so helpful if you’re new to the field.  Then the document delves into the basic concepts of KPI’s in general.  You’ll learn what criteria to use, what types of KPI’s are available, the categories of KPI’s by purpose, generating KPI’s from measurements and so on.

Section 5 is titled “Definitions and descriptions.”  It really provides you with concrete information on KPI’s themselves.  Here you’ll find a table with the basic structure of a KPI, how to present effect model diagrams, and more.

Section 6 on exchange and use provides guidance for taking the KPI data and moving it between one MOM application and another.  And Section 7 discusses relationships and dependencies.  This is visually defined with the presentation of Table 2, a model of relationships and dependencies.  Here you’ll see how the data can flow throughout the organization, and how that data is then modeled into the various KPI’s you choose to focus on.  You’ll also get computational support for verifying the effectiveness of your KPI’s.

Annex A brings the KPI primer back to the context of MOM, so you’ll be able to review the benefits, etc., of KPI’s specifically within this environment.  A 6-item bibliography completes the document.

FYI:  There’s also the ISO 22400-2 available, “Automation systems and integration – Key performance indicators (KPIs) for manufacturing operations management – Part 2: Definitions and descriptions.”  It was released at the beginning of the year.  And 2 additional parts are currently in the works — Part 3: Exchange and use and Part 4: Relationships and dependencies.

If you need a methodology for structuring the use of KPI’s in your manufacturing environment, you’ll want a copy of this new standard.  Head to the Document Center webstore at www.document-center.com and order your copy now.  It comes in both paper format and for pdf download, and you can include it in your multi-user online subscription service too!  If you’d prefer to work with our staff, you can contact them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks improve their operations by using standards effectively since 1982.  Make us your Standards Experts!

AS 9102 updated for First Article Inspection

October 8th, 2014

There are a number of quality standards developed specifically for the Aerospace Industry, and AS 9102 is among the most important of these.  Titled “Aerospace First Article Inspection Requirement,” the document has just been revised.  The new Revision B is available now from Document Center Inc. in both paper format and for pdf download.  It’s the first update of the standard since 2004.

AS 9102 provides the user with the baseline requirements for First Article Inspection (FAI), so necessary in ensuring that the item produced is the item as specified in both the contract and engineering specifications.  You’ll normally use it for a part that is representative of the first production run.  The process assures that all engineering design and specification requirements are understood and verified.

What’s new in the Revision B?  Here’s the list from SAE:

  • The new update emphasizes the value of the First Article Inspection (FAI) process to an organization
  • It separates and enhances the planning and evaluation activities
  • There’s a definition of Digital Product Definition (DPD) and its relationship to the FAI process
  • Other updates have been made in response to user comments

Over the years, the aerospace industry has come to rely on the AS 9102 not only for the guidance it provides, but also for the various forms that are included in the document.  You’ll find forms for Part Number Accountability, Product Accountability, and Characteristic Accountability included.  And instructions on how to use the forms are also part of this standard.

Why use Document Center Inc. for your purchase of this new edition?  We have options for both the delivery and purchasing methods.  Our superior notification service is included at no charge.  And our expert staff can help you maximize your use of the standard with a variety of support services.  Just go to our webstore at www.document-center.com to order.  Or contact our staff by phone (650-591-7600), email (info@document-center.com) or fax (650-591-7617).  We’ve been helping folks like you since 1982.  Make us your Standards Experts!

New IEC/TR 62511 – Power System Guidelines

October 7th, 2014

In recent years, the question of the reliability of the power grid has loomed large.  The new IEC technical report, IEC/TR 62511 provides users with design guidelines for interconnected power systems (IPS).  It is anticipated that the user of this technical report will find system reliability will be enhanced, primarily in when part of the system is down or unintentially separated.

Titled “Guidelines for the design of interconnected power systems,” IEC/TR 62511 is intended for high voltage transmission systems (generally more than 50kV).  You’ll use the guidelines during your assessment phase as well as in the reliability testing of your transmission system.  This will help you determine the elements of IPS needed for enhanced design.  Then the report gives you all the considerations to take into account as you proceed.

After the usual scope, referenced documents and definitions sections, the IEC/TR 62511 covers the complete range of issues for your review.  They include:

  • General Principles
  • Resource adequacy
  • Modeling and assessments
  • IPS design guidelines

A short 3-item bibliography rounds out the document.

Failure of the power grid has turned out to be an unpleasant consequence of increased inter-connectivity and unanticipated loads.  You’ll find that this guide will help you identify those areas where you’ll need to do an assessment of how your power grid components will behave in adverse conditions.  And it will give you an overview of how to design your system (including existing components) to minimize the risk of cascading failures when one part of the grid goes down.

If this document will assist you to meet your requirements for a high level of reliability in your integrated power system, you’ll need to get a copy.  Head to Document Center’s webstore at www.document-center.com.  There you can purchase an authorized copy in either paper or pdf format.  Or you can request to have it added to your multi-user online subscription service.  If you’d like more information, just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

We’ve been providing our customers with standards from our Silicon Valley location since 1982.  Make Document Center Inc. you Standards Experts!

New Service PPAP Supplement available

October 6th, 2014

AIAG, the Automotive Industry Action Group, has just issued a new Service PPAP Supplement for the popular PPAP 4th Edition standard, “Production Part Approval Process.”  This new PPAP Supplement is title “Service Production Part Approval Process (Service PPAP)” and is available from Document Center now.  It’s been written to clarify requirements for service part production.

AIAG notes that Service PPAP:

  • Provides PPAP expectations for serviceable components as opposed to top level assemblies
  • Clarifies service unique PPAP requirements for low volume service vs. production parts
  • Gives you guidance on applying Advanced Product Quality Planning (APQP) to service part processing
  • Outlines adequate visual aids and operator instructions needed for service processing, including routing, inspection, packaging, and labeling

Of course you may be wondering if the supplement has additional requirements you’ll need to meet.  Actually the supplement provides clarification only.  But if this is an area that applies to your operations, you’ll be pleased that the document does identify all requirements specific to your applications.

What kind of situations are covered by Service PPAP?  You’ll use it if you’re affected by remanufactured parts, service unique chemicals, third party packagers, and service software requirements.  The document allows for evidence that required customer engineering design records and specification requirements are being met by a service part supplier.  And it allows you to confirm that a supplier’s manufacturing process will produce consistent product.

Now you’ll need a copy of the new Service PPAP.  Head to Document Center’s webstore at www.document-center.com and order your copy there.  Or you can contact our staff by phone (650-591-7600), email (info@document-center.com) or fax (650-591-7617).  We’ve been providing our customers with standards since 1982 from our Silicon Valley location.  Make us your Standards Experts!

New ISO/DIS 14644-2 – Cleanroom Monitoring

October 3rd, 2014

In tandem with the release of ISO/DIS 14644-1 (reviewed in Wednesday’s StandardsForum.com blog), there’s been the release of ISO/DIS 14644-2.  It’s a proposed revision of ISO 14644-2 to be titled “Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.”  You’ll get the draft to take a look at possible changes to the document and to allow for comments that you might want to make to the committee regarding these proposed updates.

The difference between ISO 14644-1 and ISO 14644-2 is that the Part 2 provides you with information on air cleanliness over time, rather than just a one-time at-rest reading.  Developing a strategy for this type of monitoring allows for more effective risk analysis, with potential for reduction of operational and product losses.

Some of the things you’ll notice that are different in this proposed 2nd edition are the expansion of the requirements from Section 3 on terms and definitions and Section 4 on demonstration of continued compliance.  In the draft, there are 3 areas of requirements:

  • Section 3 on terms and definitions
  • Section 4 on creating, implementing and maintaining a monitoring plan
  • Section 5 on periodic classification of air cleanliness using particle concentration (ACP)

The informative Annexes have also been revised.  Now Annex A covers matters to consider when developing your monitoring plan.  Annex B provides you with considerations for setting alert and action levels.

As you can see, use of the document over time has resulted in a different slant to the content of the standard.  Since this is a draft, the changes are not yet authorized.  However, many folks do find it helpful to understand the direction of future requirements.  If you’d like to review the new document, you’ll need a copy.  You can order yours at the Document Center website, www.document-center.com.  Or you can contact our staff by phone (650-591-7600), email (info@document-center.com) or even by fax (650-591-7617).

Since comments are due by November, this gives you some time to reflect and possibly contact the committee with your opinions.  And if you need a resource that not only provides you with standards but also provides you with additional services to make them easier to use, you’ll be glad you’ve chosen Document Center.  We’ve been supporting standards users like you since 1982.  Make us your Standards Experts!

New ISO 10993-3 3rd Edition – Biological Evaluation of Medical Devices

October 2nd, 2014

Medical device manufacturers need to do a battery of testing prior to the release of any products as part of regulatory and quality requirements.  Biological evaluation, the interaction of the device with biological tissues, is a major concern.  So those in the medical device industry will want to know that there’s a new 3rd Edition available for ISO 10993-3.  Titled “Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity,”  this is part of the 19-document series from ISO.  It is a technical revision of the 2nd edition (which is now obsolete) and is 42 pages in length compared to the previous 23 page revision.

What are the changes in the ISO 10993-3 3rd Edition?  As you can see from the additional pages, there’s a lot of new material.  Let’s review the areas where the standard has been updated:

  • The test strategy of the standard has been modified by the addition of an in vivo test and follow-up evaluation.
  • There’s a new Annex A which provides guidance on selecting the appropriate sample preparation procedure in genotoxicity testing.  This includes further in vitro and in vivo tests.
  • There’s also a new Annex B that’s a flowchart for follow-up evaluation.
  • Annex E has been changed to “Considerations for carcinogenicity studies performed as implantation studies.”  This is a requirement now, not just informative.
  • And there’s a new Annex F on in vitro tests for embryo toxicity as well.

Other news for those of you who use this standard — A new ISO 10993-33 is in the works.  When it is published, it is expected that the title will be “Biological evaluation of medical devices – Part 33:  Supplement to ISO 10993-3: – Guidance on tests to evaluate genotoxicity.”  The document should be released as a Technical Report.

You’ll want to purchase a copy of the new edition, so head to the Document Center Inc. website at www.document-center.com and order your copy now.  You’ll be able to get the standard in both paper format and for pdf download.  If you’d like to have it as part of our Standards Online multi-use subscription service, contact our staff by phone (650-591-7600), email (info@document-center.com) or fax (650-591-7617).  We’re here to assist you with your compliance documentation requirements.  Make us your Standards Experts!

ISO/DIS 14644-1 Draft Issued for Cleanrooms

October 1st, 2014

ISO 14644-1, “Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness,” has been the go-to document for cleanrooms here in the U.S. ever since FED-STD-209 was cancelled back in 2001.   Now ISO Committee TC 209 has issued the ISO/DIS 14644-1 draft for a proposed 2nd Edition.  If you like to take a look at upcoming changes, or make comments, this is your chance!  Voting on this draft document will happen on November 18th.  But you’ll need a copy in order to review the updates and you can get yours from Document Center Inc. now.

ISO 14644-1 provides you with information on how air cleanliness is classified according to the concentration of particulate matter.  It’s one of an 11 part series addressing the whole issue of cleanrooms and is the starting point for implementation of the series.

The new draft ISO/DIS-14644-1 covers classification of particle populations based on particle size that has a lower limit of 0.1 µm to 5 µm.  It uses  light scattering (discrete) airborne particle counters (LSAPC) to determine the concentration of these particles.  This is done through the use of designated sampling locations.

Of course, until the draft is adopted and published, the current ISO 14644-1 1st Edition remains current.  However, if both parties agree, the new draft document can be referenced in contracts.

If you’re in the aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, or food industries you may find a need to provide a controlled environment during processing.  This is where the ISO 14644 series comes in, since it is the core standards set for accomplishing contamination-sensitive activities.

You’ll want to get copies of the appropriate parts and even the draft documents as well.  And there’s no better place to order than from Document Center.  Our webstore is available at www.document-center.com.  You’ll find it easy to work with and it has lots of features that can help you identify and monitor the standards you need.  Want to work with our staff to get personal service?  Contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing standards from our Silicon Valley location since 1982.  Make us your standards experts!

New Option for EN standards from Document Center Inc.

September 30th, 2014

Looking for a less expensive source for EN standards?  Here at Document Center Inc. we’ve been looking for one too!  Now we are pleased to announce that we have signed an agreement with the Swedish Standards Institute to make the SS Editions of the EN standards available to you!  You’ll find the SS EN standards listed in the Document Center online webstore, with a wide range of delivery options.  And the prices are very attractive!

Are the SS EN editions the same as BS EN and DIN EN editions?  Yes!  They contain the same EN document as the other national editions.  Only the cover sheet material changes from national publication to national publication.

Are the SS EN editions available in English?  Yes!  The standards listed at the Document Center webstore are all available in English, the exact same text as in the other English language national editions.

Are the SS EN editions available for paper format delivery as well as for pdf download?  Yes!  You order these standards in both paper and pdf format right in our store.  They will be sent to you directly when we get your order.

Can I get multi-user licensing access for SS EN standards?  Yes!  All SS editions on our website are available as part of our Standards Online multi-user subscription service.  This means you can have legal access throughout your organization to the EN standards you use.

Are the prices for the SS EN standards reasonable?  Yes!  They are the least expensive editions for most of the EN standards we carry.

Do I have to purchase the whole document over again when an amendment or corrigendum is issued?  No!  With the SS EN standards, you can purchase just the component you need, which will save you a lot of money.

As you can see, Document Center Inc. is really pleased to have such a great partner to allow for more flexibility for our customers, and at a price savings as well!  You’ll find the Swedish Standards Institute to be prompt in it’s adoption of EN standards, so that the lag time between the issue of a new EN document and the national publication will be minimized.  So you’ll get a lot of benefit from choosing the SS EN editions for your standards collection.

Just go to Document Center’s Webstore at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We will be able to help you make the transition from other national editions to the SS EN editions.  It’s just part of our mission to help you procure and use standards more effectively!  Make us your Standards Experts!

New MIL-PRF-55110 Revision H on Rigid PWB’s

September 29th, 2014

MIL-PRF-55110, “Printed Wiring Board, Rigid, General Specification for,” has just been revised.  The new Revision H is the first update since Revision G was released with Amendments 1 through 3 back in 2008.  While the specification is inactive (you’ll use MIL-PRF-31032 for new design), it is still widely used for replacement purposes.  If you use the document, you’ll want to get your new edition now.  Compliance with the new Revision H must be completed by April 17, 2015.

The document was originally released as MIL-P-55110, “Printed Wiring Board, General Specification For.”  As part of Mil Spec reform back in the 1990′s, the document was re-classified as a performance specification and given the new number MIL-PRF-55110 to reflect the change.  About 6 months after the transition, the document was inactivated.  However, it continues to be maintained and widely used.

It’s been 6 years since the last update, so changes are extensive (no notations in the margins to help you spot revised material in this new publication).  You’ll expect that as with previous updates, your documentation and processes will be affected.  Having said that, the new Revision H is significantly longer than the previous Revision G.  Why all the new material?  The addition of a number of new Appendices.  Let’s review them:

  • Appendix A – Now Product Assurance Requirements for Qualified Products List Level
  • Appendix B – Now Product Assurance Requirements For Qualified Manufacturer List Programs
  • Appendix C – Still C = 0 Sampling, Test Equipment, And Inspection Facilities
  • Appendix D – Still Supersession, Conformance Inspection Options, And Use Of Legacy Design Standards
  • Appendix E – Now Qualification Requirements For All Levels Of Product Assurance
  • Appendix F – New External Visual And Dimensional Illustrations
  • Appendix G – New Metalographic Illustrations
  • Appendix H – New Quality Conformance Test Circuitry

You’ll notice that the old Appendix E on Sequential Electrochemical Reduction Analysis (SERA) solderability testing is not included in this new edition.

If you use MIL-PRF-55110 in your business, you’ll want to get a copy of the new Revision H.  It’s available to order on the Document Center website, www.document-center.com.  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been supporting the electronics and defense industries since our inception in 1982.  Make us your Standards Experts!