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ISO 8637 Replaced by ISO 8637-1 on Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators

ISO 8637, the standard for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, has been withdrawn. It has been replaced with the new ISO 8637-1, Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. This is the first of a planned 3-part series for blood purification systems. It is a technical revision, so you will need to migrate from the old edition to the new one.

What does the ISO 8637-1 cover? Of course it is for devices used in haemodialysis, haemodiafiltration, haemofiltration and haemoconcentration in humans. It addresses safety issues and functionality. Dimensions of blood and other ports are specified. These design and dimension requirements are intended to reduce the risk of leakage of blood and the intake of air. The standard does not include information on applicable materials for construction. You’ll use materials that have been tested for biocompatibility, etc. Results of this testing should be available upon request.

What are the technical changes? The committee notes that this is a technical revision. They also point out that the Figures 1, 2, and 3 have been revised.

What are the other planned parts for the new ISO 8637 series?

ISO 8637-2, Extracorporeal systems for blood purification — Part 2:
Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

This part is currently at the final draft stage and should be available soon. It will replace the existing ISO 8638 on the same subject.

ISO 8637-3, Extracorporeal systems for blood purification — Part 3: Plasmafilters

Again, this is currently a final draft, which means publication will occur soon. This part will replace the current ISO 13960 on the same topic.

Please note: The ISO 8637 has been adopted by the European Union as EN ISO 8637. Expect that adoption of the replacement document will happen shortly. Supersession information will be available as the administrative process of the EU is completed.

Now you’ll want to get your copy of the new standard. Use Document Center Inc. for your purchase — you’ll find these publications at our webstore, www.document-center.com. Here is a direct link to the order page for the ISO 8637-1 for your convenience. Remember, we are an authorized distributor for ISO standards and your purchases from us are in compliance with all copyright laws.

Does your standards supplier notify you when items you’re using are replaced by other standards? Document Center Inc. does this and more. To learn about the support services we offer, get in touch with our staff. You can reach us by phone (650-591-7600) and email (info@document-center.com). We can help you manage and improve your compliance efforts, so make us your Standards Experts!

AS 9104 Withdrawn in favor of AS 9104/1, AS 9104/2 and AS 9104/3

AS 9104, the SAE Aerospace Standard on Requirements for Aerospace Quality Management System Certification/Registrations Programs, has been withdrawn. This standard is part of the As 9100 series of Aerospace Quality Management Standards used extensively by the industry. The replacement documents, the AS 9104/1, AS 9104/2, and AS 9104/3, divide the content of the original AS 9104 into parts.

The last edition of the AS 9104 (Revision B) was released in 2005 and reaffirmed in 2013. Shortly after the Revision B release, the caretaker organization (the International Aerospace Quality Group – IAQG) decided it was too complex. Work was undertaken to divide this standard on all aspects of what’s called Industry Controlled Other Party (ICOP) quality management into 3 sections. These are the superseding parts 1, 2 and 3.

Let’s take a look at the 3 replacement parts:

AS 9104/1, Requirements for Aviation, Space, and Defense Quality Management System Certification Programs

This part was released in 2012. It is the “keystone” document of the set. The series is used to insure quality throughout the supply chain. How? By creating a methodology for testing and certifying suppliers to the industry that can be accepted internationally. This overview document provides the general requirements for meeting this scheme.

AS 9104/2, Requirements for Oversight of Aerospace Quality Management System Registration/Certification Programs

This part was originally released in 2007 and updated with Revision A in 2014. It provides a robust oversight process to ensure conformance to the requirements of the series. It does so by establishing oversight committees and teams of assessors, and setting requirements for assessments and assessment tools. Assessment reporting is also standardized here.

AS 9104/3, Requirements for Aerospace Auditor Competency and Training Courses

As this part from 2007 states, an assessment program is only as good as the assessors. As with many quality auditing systems, need for common requirements for the assessors is a must. This standard relies on the criteria established by the ISO 19011 section 7 as well as the ISO/IEC Guide 62. You’ll need to have auditors who meet these specific requirements for competency and have passed the required training courses defined in this Part 3.

To get your copies of these replacement standards, head to the Document Center Inc. webstore at www.document-center.com. We have been an authorized distributor of SAE standards since the 1980’s. You’ll be able to purchase your copies in paper format, for pdf download, or as part of our Standards Online cloud enterprise service. Links to each of the parts are provided in the text above. All purchases come with our “best-in-class” notification service at no additional charge.

If you need a copy of the cancelled Revision B for the AS 9104 itself, please let us know. It is available from Document Center Inc. Just reach out to us by phone (650-591-7600) or email (info@document-center.com). Find out why so many companies make us their Standards Experts!

ISO/IEC 12207 Updated and Renumbered as ISO/IEC/IEEE 12207

ISO/IEC 12207 has been updated. Along with the technical updates, the document has been issued under a new publication number, ISO/IEC/IEEE 12207. This new 1st Edition replaces the old number’s 2008 2nd Edition. The title remains the same, Systems and software engineering – Software life cycle processes.

Confusion over the document’s number is understandable. This is a standard that originated at IEEE when it was first released. Over the years, it has moved to the jurisdiction of ISO/IEC’s Joint Technical Committee 1 (JTC1) in cooperation with IEEE. So both ISO/IEC and IEEE have released this new document at the same time. To differentiate the 2 separate editions (as well as price correctly and meet our contractual obligations to each organization), we have the item in our system multiple times. However, each entry is a bit different.

You’ll find the international edition as ISO/IEC/IEEE 12207, in both paper format and for pdf download. The IEEE edition is available in paper format as IEEE/ISO/IEC 12207. It is available for pdf download as IEEE/ISO/IEC 12207-P. The document is also available as part of our Standards Online cloud enterprise solution. The standard is identical no matter how you get it. However, the prices will vary.

Why a new edition for the ISO/IEC/IEEE 12207? The document needed to be harmonized with the ISO/IEC/IEEE 15288 from 2015. Areas that were creating difficulties were the variations in terminology and the process structure of each. So this new edition provides a pathway towards a harmonized future, but not forgetting backward compatibility. It is a technical update and replaces all previous editions.

How will you get your copy of this new update? Use the Document Center Inc. webstore at www.document-center.com. Here you can search for and order standards with confidence. We are an authorized distributor of ISO, IEC, and IEEE publications. You’ll note that links to the 3 different formats for the publication have already been provided above.

Why use Document Center? In addition to copyright compliance, we offer a wide spectrum of support services for companies in all sectors. These range from notifications to reports, from multiple purchasing options to a variety of ways you can have your standards delivered. We have been selling standards since 1982 and remain a staunch advocate for compliance. To learn more, get in touch with us by phone (650-591-7600) or email (info@document-center.com) Then make us your Standards Experts!

ISO 10006 for Quality Management of Projects Updated

ISO 10006 has just been updated. The new 3rd Edition is dated November, 2017. It’s titled Quality management – Guidelines for quality management in projects. The new 2017 Edition replaces the 2nd Edition from 2003, which has been technically revised. The ISO 10006 is a supporting standard. It provides you with guidance and is not a management system standard.

I feel like I’ve been saying this a lot lately, but the new revision was instigated to align this standard with the 2015 Editions of ISO 9000 and ISO 9001. FYI: the update also supports the 2012 Edition of ISO 21500, on project management. To help you make the connections between the documents, Annex B is a matrix with the cross references between the ISO 10006, the ISO 9001 and the ISO 21500.

The 42-page ISO 10006 provides you with quality management principles and practices for projects. You’ll use it for both goals of quality in internal project processes and the quality of the project’s resulting products and/or services. It doesn’t matter if your organization is small or large. You’ll just use the level of detail that matches your particular situation.

The document begins with the usual scope, referenced documents, and definition sections. Clause 4 covers quality management systems in projects. Next, the management responsibilities for quality are reviewed. Clauses 6 through 8 provide you with information on other important areas. These include resource management, product and service realization, and measurement, analysis and on-going improvement. Annex A is an overview. Annex B is the matrix we discussed earlier. And the publication finishes up with a 15-item Bibliography.

To get your copy, you’ll use an authorized ISO distributor like Document Center Inc. Search for and order the standards you need at our webstore, www.document-center.com. Here is a direct link to the order page for ISO 10006 for your convenience. And the standard has been adopted by the European Union as EN ISO 10006. Expect the EN and its national adoptions to be updated with the new information in the future.

Document Center Inc. has been selling standards since 1982. We have an extensive collection of standards to support your compliance requirements. And we offer a range of products and services that will improve the way you manage your documentation as well. Discuss your needs with our staff. You can reach us by phone (650-591-7600) or email (info@document-center.com). Don’t forget, we’re your Standards Experts!

ISO 9564-1 2017 for PIN security

ISO 9564-1 for personal PIN security has been updated. The new 4th Edition is available from Document Center Inc. in paper format, for pdf download and as part of our enterprise cloud solution, Standards Online. The full title of the standard is Financial services – Personal Identification Number (PIN) management and security – Part 1: Basic principles and requirements for PINs in card-based systems. The new 40-page update replaces the previous 3rd Edition with its Amendment 1, which is now obsolete.

Of course, we are all concerned these days with having our credit and debit cards compromised. A PIN (Personal Identification Number) system is one tool created for cardholder verification. Used correctly, it should be protected throughout the electronic funds transfer (EFT) cycle. When we use cards that depend on PINs, we are unaware of the process that actually completes the transaction. However, there are a number of discrete steps that all involve the use and protection of our PIN and other confidential information.

The ISO 9564-1 provides financial technology firms with the requirements for sound key management in these types of transactions. And it also includes requirements for proper management of PIN information. It is specifically designed for use in the retail banking industry and those institutions that partner with those banks to convey customer card information.

As to the updates in the new 4th Edition, the committee notes that the revision is a technical update. However, further guidance is not provided. I do want to mention that the ISO 9564-1 has been adopted by the European Union and that the 2017 Edition of EN ISO 9564-1 is now released.

Compliance with this standard will be essential for the industry. Breaches of banking information create not only financial losses, but also the loss of consumer confidence. No institution should find itself out of compliance with the best practices that the 4th Edition of ISO 9564-1 represents.

That’s where Document Center Inc. comes in. As an authorized distributor of the ISO standards, we can supply you with copies of the latest editions in a format that best suits your needs. And all purchases come with our “best-in-class” notification service, so you’ll always know when your standards are updated.

Use our webstore www.document-center.com to search for and order the standards you need. Here is a direct link to the order page for ISO 9564-1 for your convenience. We also have a number of other support services to aid your document control function. To learn more, check in with our staff by phone (650-591-7600) or email (info@document-center.com). Learn why so many companies make us their Standards Experts!

MIL-PRF-38534 Hybrid Microcircuit Specification

MIL-PRF-38534 for hybrid microcircuits has been revised. The new Revision K is available from Document Center Inc. now. It’s titled Hybrid Microcircuits, General Specification for. The performance specification replaced the obsolete MIL-STD-1772 back in 1996. It’s used for meeting the requirements for hybrid microcircuits used in government procurement. If you use this specification, you’ll need to meet the new updates by May 15, 2018.

The 175-page MIL-PRF-38534 Revision K covers hybrid microcircuits, multi-chip modules (MCM) and similar devices. Verification requirements are provided so that the manufacturer can meet applicable performance requirements for U.S. military use. Appendix A authorizes the use of 1 of 2 listed quality programs to verify compliance. Also included are the requirements for QML listing (Qualified Manufacturers List). FYI: The QML information is now maintained in a database by the Department of Defense.

This is an overview document, with detailed specification requirements provided by SMDs (Standard Microcircuit Drawings) and other specifications. In order to have your products authorized for procurement and for inclusion in products sold to the military, these general requirements must be met. So Appendix C defines generic performance verifications, Appendix D is on generic performance requirements for non-hermetic device technologies, and so on.

For those of you using the publication, you’ll want to know where the changes in the specification are. Instead of the usual black lines, asterisks are provided in the margins notating where the changes have been made. As usual, the document notes that these have been provided as a convenience only. This means that if there are changes that were not marked, you’ll still be liable if you don’t meet the update.

Of course, you’re going to need this new update, since there are many changes throughout the specification. Use Document Center Inc. for your purchase. We provide you with options for delivery format and for payment. And all standards sales come with our “best-in-class” notification included in the price of the publication. You can search for and order government standards and other publications at our web store, www.document-center.com. Here is a link directly to the order page for MIL-PRF-38534.

Document Center Inc. has been working with the defense contracting community since 1982. We have a good understanding of the challenges facing this sector and products and services to make your life easier. To learn more, reach out to us by phone (650-591-7600) or email (info@document-center.com). We are your Standards Experts!

ISO/IEC 17025 2017

ISO/IEC 17025, the important calibration standard, has just been updated. It is titled General requirements for the competence of testing and calibration laboratories. The new 3rd Edition from November 1, 2017 is available now from Document Center Inc. It is a technical revision of the previous 2nd Edition dated 5/15/2005. This means that the 2nd Edition is obsolete and replaced by the 3rd.

ISO/IEC 17025 contains the requirements that calibration labs have to meet in order to be ISO/IEC certified. This is the way that calibration labs demonstrate the ability to provide valid results for their customers. And it is also used to provide competency assurances for cross-border regulatory compliance in international trade.

As with many of our management standards, ISO/IEC 17025 has undergone a transformation with regards to risk management concerns. With this risk-based approach comes new requirements and modifications for what were formerly prescriptive ones. The focus on performance-based requirements is one of the primary changes in this new 3rd Edition.

Another big change in the standard is the new flexibility in a number of areas. These include processes, procedures, documented information and organizational responsibilities. Again, this is a reflection of the impact of the new ISO 9001 2015 Edition. Laboratories will be focused on results and flexibility in achieving the goals of competence, impartiality and consistent operations.

FYI: The word “laboratory” is now part of the definitions section in Clause 3.

No matter the size of your calibration laboratory, you’ll want this new update. Be sure to purchase your copy from an authorized distributor like Document Center Inc. You can order with confidence at our secure web store, www.document-center.com. Here is a direct link to the order page for ISO/IEC 17025 for your convenience.

All standards sales come with our “best-in-class” notification service at no additional charge. So Document Center Inc. customers who have purchased previous editions of this standard already have received their email alerts regarding this update. To learn more about the support services we offer to our customers, please contact us. You can reach us by phone (650-591-7600) and email (info@document-center.com). You’ll soon learn why so many companies make us their Standards Experts!

IEC TR 63097 – Roadmap for Energy Smart Grid Standards

IEC TR 63097, the Smart grid standardization roadmap, has just been released. It’s a new 320-page Technical Report outlining the way forward in developing the smart power grid. Companies need to prepare for the long-term impact of technology and interconnectivity. Without widespread adoption of compatible standards, the development of next level power grid applications will not be possible.

IEC TR 63097 is an example of the importance of standards development supporting technology advances. This model of setting standards in advance of technical product development and implementation springs from the telecommunications industry. With ITU in the lead, that industry has been setting global requirements prior to actually providing products and services. This is quite unlike the traditional standards process, where standardization is the final step in the process.

In any sector facing rapid technological changes, a common question is “What standards should I be using?” The IEC TR 63097 provides you with guidelines to select the most appropriate set of standards and specifications supporting the smart grid. However, in some cases, those standards have yet to be completed.

So what will you find in the IEC TR 63097? The document begins with the usual scope, referenced documents and definition sections. Then it discusses the Smart Grid context, including drivers and definitions of the Smart Grid itself. The bulk of the text of the standard is contained in Clause 5. It’s divided into 10 sections, each on a specific area of concern. These may be general, like Clause 5.1 with its high-level summary or 5.2 on the general framework. Other sections present information like the use of the Smart Grid standards map, use cases, interoperability, expected evolutions, cross-cutting technologies, and standards for specific areas relating to smart grids.

There are 2 Annexes. Annex A consists of a series of tables, presenting a list of standards on the left and the technical areas covered by each standard on the right. Annex B covers core IEC Standards for smart grids. Each standard or standard series is reviewed with text and figures (like graphs and the like). These Annexes are informative only, but of great assistance to the user.

To get your copy, you’ll follow IEC’s instructions to purchase from an authorized distributor like Document Center Inc. Our webstore at www.document-center.com has been selling the IEC standards under license agreement since the 1993. Here is a direct link to the order page for IEC TR 63097 for your convenience.

Document Center standards purchases come with our “best-in-class” notification as part of your transaction. Other compliance documentation products and services are available as well. For more information, contact us by phone (650-591-7600) or email (info@document-center.com). Find out why so many people make us their Standards Experts!

ISO/IEC 27019 – IT Security for Energy Utilities

ISO/IEC 27019 has just been released. The new standard is titled Information technology – Security techniques – Information security management guidelines based on ISO/IEC 27002 for process control systems specific to the energy utility industry. It is the revision and upgrade of the ISO/IEC TR 27019, which is now obsolete.

If you worry about the security of our energy sector (and I do), you’ll be glad that this standard has reached this landmark “standard” status. The previous edition was a Technical Report, which doesn’t carry the same weight as a standard. Also of note is the expansion of the scope of the document to include the energy oil sector.

The standard itself provides principles based on the ISO/IEC 27002, Code of practice for information security controls. This new 2017 Edition of the ISO/IEC 27019 references the 2013 Edition of the Code. You’ll use it for information security management for process control systems in this sector. So much of the information requirements of the energy utility industry center on process control functions. So you can see that security for this data is essential.

The standard is organized in the usual fashion, with the scope, references, and definition clauses to start. Next you’ll find a section on the structure of the standard. The next clauses cover information security policies, the organization of information security, and human resource security. The standard then covers asset management, access control, and cryptography. Of course, physical and environmental security are important and included in Clause 11. Clause 12 and 13 address operational and communications security. Next, system acquisition, development and maintenance requirements are covered. Clause 15 is on supplier relationships and 14 covers incident management. The final 2 Clauses are on information security aspects of business continuity management and compliance.

The 44 page standard has a required Annex A on energy utility industry specific reference control objectives and controls. And a 10-item bibliography is provided at the end of the document.

You’ll use an authorized distributor like Document Center Inc. for your purchase. You can search for and order standards at our webstore, www.document-center.com. Here is a direct link to the order page for the ISO/IEC 27019 for your convenience.

Remember, Document Center Inc. has been selling standards since 1982. We are here to support your use of compliance documentation. So contact us by phone (650-591-7600) or email (info@document-center.com) to learn more. Then make us your Standards Experts!

JESD 69 Updated for Silicon Device Qualification Information

JESD 69, Information Requirements for the Qualification of Silicon Devices, has just been updated. The new Revision C is available from Document Center Inc. now in both paper format and for pdf download. It provides both suppliers and customers with the minimum requirements for information provided for the device qualification package (for silicon devices).

What is this about? It’s information on a specific set of data elements that describe a particular device. This includes the test results of a supplier’s qualification efforts. Of course, the tests a supplier uses may vary from device to device. The standard does not include specific information on what tests must be done for any particular device.

For those of you already using this standard, you’ll want to know what the changes are since you may need to change your protocols. The JEDEC committee in charge of the JESD 69 has provided us with a synopsis of the updates. You’ll find them in Annex A. Now the previous Revision B (from October 2007) is obsolete with the release of this technical update. So an understanding of the new requirements is essential.

First of all, you’ll notice that the word “component” has been replaced with the term “device.” There are references to more standards in this new update. Clause 3 has additional clarification of items to be included in the report. Clauses 3D and 3F have also been revised.

Now to get your copy of this new JESD 69 Revision C. Head to the Document Center Inc. webstore at www.document-center.com. There you will find all standards from JEDEC, since we are an authorized distributor of these publications. Historical editions are also available. Here is a direct link to the order page for the JESD 69 for your convenience.

Your purchase will come with our “best-in-class” notification service at no additional charge. And we have a number of products and services geared to help you maintain compliance for your documentation collection. To find out more, check in with our staff. We can be reached by phone (650-591-7600) or email (info@document-center.com). Learn why so many companies make us their Standards Experts!