ISO has just released 2 new documents in the ISO 11608 series and both are available now from Document Center Inc. They are the new ISO 11608-1, “Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems,” and ISO 11608-2, “Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles.”
ISO 11608-1:2012 covers needle-based injection systems (referred to as NISs) primarily intended for human use. It provides performance requirements regarding essential aspects so that variations of design are not unnecessarily restricted. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.
The first edition of ISO 11608-1 in 2000 introduced the concept of interchangeability and the labeling designations “Type A” (i.e. interchangeable) and “non-Type A” for needles and container systems. Since it was released, experience has shown that the complexity of these systems makes it very difficult to ensure functional compatibility, particularly when products are made by different manufacturers.
Based on this experience, the labelling designation “Type A” has been removed. The design requirements related to system function have been maintained as a guide to assist manufacturers during the design phase, supporting the achievement of cross-platform compatibility. However, these design requirements are an insufficient replacement for system testing of the components and, where possible, direct communication and/or quality agreements between system component manufacturers.
Given the patient convenience benefits associated with cross-platform compatibility, manufacturers of needles, containers and needle-based injectors need to label their products with the specific system components that have been tested and demonstrated to be functionally compatible.
ISO 11608-2:2012 covers sterile double-ended needles intended for single use in conjunction with needle-based injection systems (e.g. pen injectors). These needles are often referred to as pen needles.
Again, the labelling designation “Type A” has been removed. Flow rate is introduced as a new parameter. However, this part of ISO 11608 does not specify requirements or test methods for freedom from biological hazards because no international agreement on the methodology and the pass/fail criteria has been reached.
The sampling plans for inspection selected for this part of ISO 11608 are intended to verify, at a high confidence level, the manufacturer’s ability to manufacture one “lot” of needles that conforms to the critical product attributes. The sampling plans for inspection do not replace the more general manufacturing quality systems that appear in standards on quality systems, for example ISO 9000.
The other standards in this series are:
ISO 11608-3:2000, “Pen-injectors for medical use — Part 3: Finished cartridges — Requirements and test methods”
ISO 11608-4:2006, “Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors”
ISO 11608-5, 2011 Draft, “Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions”
ISO 11608-3 is due to be revised soon.
All ISO standards, and many obsolete revision as well, are available from Document Center Inc. at our website, www.document-center.com. Or you can get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can assist you with all your compliance documentation requirements.
ANSI’s response to the OMB Circular A119 petition on Free Internet Access to Standards incorporated into Federal Regulations
Tuesday, April 17th, 2012Last week I blogged about the petition by a group of academics led by Professor Peter Strauss regarding the availability of standards incorporated by reference in the Code of Federal Regulations (CFR’s). ANSI, as the umbrella organization for U.S. standards developers, has sent in a reply addressing a number of questions raised by NARA, the National Archives and Records Administration, the executive branch that oversees that part of the CFR addressed by the petition.
The first area of concern for NARA was the meaning of “reasonably available,” existing language in the circular which is at the center of the discussion. ANSI’s position is that the text of standards and associated documents should be available to all interested parties on a reasonable basis, which includes appropriate compensation as determined by each SDO (Standards Developing Organization).
ANSI brings up the fact that the accessibility of information on the Internet has not diminished the protections of copyright. They additionally note that online access has not “…changed the need and the ability of standards developers to cover the significant costs of creating the documents that are used to further public policy goals in law and rulemaking.”
ANSI also points out that requiring various agencies to purchase licenses for public access to standards incorporated into regulations would defeat the original intent of Circular A119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.”
The ANSI response notes that if agencies subsidize the costs of certain standards by licensing, then “budgets will need to be substantially increased in order to pay such costs, either through taxes or additional interest on the national debt.” This is precisely the kind of costs that OMB Circular A119 intended to avoid!
Other areas of concern for NARA, and by extension for ANSI, are articulated in the recent Recommendation issued by the Administrative Conference of the United States. The ACUS recommendation addresses many of the issues raised by the academic’s petition.
ACUS, an independent agency of the Federal Government, provides suitable arrangements through which the various agencies may cooperatively study mutual problems, exchange information, and develop recommendations for action with regards to regulatory activities and other Federal responsibilities.
The recommendation suggests that agencies should work with the various SDO’s to promote (not mandate) free access to standards referenced in U.S. regulation. The Conference’s research revealed that some agencies have successfully worked with copyright owners to further the goals of both transparency and public-private collaboration.
For example, some agencies have secured permission to make a read-only copy of incorporated material available in the agency’s public, electronic docket during the pendency of the rulemaking proceeding relating to the material. In other cases, the copyright owner has made the material publicly available in read-only form on its own Web site. The ACUS recommendation therefore encourages agencies to take steps to promote the availability of incorporated materials within the framework of existing law.
The recommendation has a total of 18 line items to promote effective use of standards within the regulations of the U.S. Since this encourages increased availability but does not mandate free access, ANSI supports the adoption of the suggestions by NARA.
Document Center Inc. congratulates ANSI on an articulate and timely response to NARA’s request for comment. This is a subject that concerns both Standards Developers and Intellectual Property owners in general. Use of copyright material, patents, and so on in public documents requires a fine balancing act between the needs of society and the rights of the property owner.
The petition reminds us that the perception of access to standards and other copyright material can be improved. Document Center actively promotes new ways for the public to find and purchase the standards they need. Hopefully the suggestions of ACUS will encourage Federal Agencies and SDO’s to continue to work together to come up with innovative solutions to this complex problem as well.
Tags: 1 CFR Part 51, ANSI Response to Request for Comments on Incorporation by Reference, Free Standards on the Internet, NARA 12-0002, OMB Circular A119
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