[summary] MDSP standard dispute. The dispute over reference standards is a hot topic in MDSP industry for a long time. The protagonist of the dispute is the United States, iso11607 series standards recognized by ISO and en868 series standards of EU. The author has the honor to read all kinds of authoritative standards and relevant information about MDSP, such as 2003 and 2006 editions of iso11607, en868 series standards, and GB / t19633 Standard Guide
MDSP standard dispute
The dispute over reference standards is a hot topic in MDSP industry for a long time. The protagonist of the dispute is the United States, ISO 11607 series standards recognized by ISO and en868 series standards of EU. The author has the honor to read all kinds of authoritative standards and relevant information about MDSP, such as 2003 and 2006 editions of iso11607, en868 series standards, GB / t19633 Standard Guide, draft version of national standard based on en868 series standards, and intaglio printing of Relevant ASTM and ISTA detail standards, such as ASTM f88, ASTM f1980, ASTM f1929, ASTM f1886, ASTM d4169, ASTM f1140 and ISTA 1a, ISTA 2a and ISTA 3a And so on.
China has issued a general standard GB / t19633-2005 based on iso11607-2003. Recently, the author inadvertently learned that China will update the MDSP standard to replace the newly issued but not very practical standard. This is a good reason for the author to write this article about the dispute of domestic MDSP standards.
I agree with the initiative of the relevant national departments (under the centralized management of Shandong Medical Device Research Institute), because iso11607-2003 is a transitional version of intellectual property rights, which has been written in 2000. The intention is to upgrade and improve the first version of iso11607-1997, and I hope to integrate iso11607-1997 and en868.1-1997 into the upgraded version.
However, it is a pity that the ISO official is not satisfied with this transitional version of the standard. Although AAMI (American Association for the promotion of medical devices), one of the co authors of iso11607, officially published the MDSP standard TIR 22 water supply / lubrication version in 2000, the ISO official did not officially launch the official version of iso11607-2003 until 2003. The author thinks that iso11607-2003 standard, as a general standard of macro guiding significance, is really unsatisfactory. In many places, the operability is not high, and the control and requirements for medical device manufacturers and MDSP suppliers are also reflected in the macro aspect, which cannot be effectively implemented. But it can't be denied that the printing and Packaging City, although the latest edition of iso11607 officially issued in 2006 still leaves a strong shadow of 2003 edition, but according to the author's careful study, iso11607-2006 is a relatively complete, reference value, and global authoritative MDSP standard general principles.
This can also explain why iso11607-2003, which was officially promulgated only three years ago, was eliminated by the new 2006 version, because it is only a transitional version after all. These events are mentioned in the article about global MDSP unification described by Dr. Michael scholla of DuPont company, vice chairman of the editorial board of iso11607.
The new iso11607-2006 is a high fidelity printing edited by the packaging director of a famous medical device manufacturing company, that is to say, it is compiled under the guidance of MDSP users (while China's packaging standards are usually compiled by packaging suppliers). For example, one of the two main directors is PTC (package technology CE), an international medical device giant, American cardinal company Nick Fortis, director of nter (Packaging Technology Center), John spitzley, the packaging director of Medtronic, the largest medical device manufacturer in the world, Shanghai Guanghua, the other are also the packaging directors of major medical device companies in the United States, such as cr.bard, Johnson & Johnson, Abbott hospita, Kimberly Clark, etc., from There are very few providers of medical devices, only Dr. Michael scholla of DuPont.
Although iso11607-2006 inherits the main idea of iso11607-2003, it also makes a great change in the award, for example, the content is divided into two parts, the first part is mainly about packaging materials, aseptic barrier system (SBS) and packaging system, the second part is mainly about the verification of MDSP, so the sterilization packaging is verified according to the packaging system design and packaging process It is very wise to distinguish the two main contents.
In the first part of iso11607-2006, the concept of "sterile barrier system (SBS)" is creatively put forward. At the same time, it also takes into account that packaging is a complete system composed of interaction between materials, materials and equipment, which can not be separated from the previously ignored fact (unfortunately, at present in China It also stays at this level of understanding, that is, to split packaging elements such as materials and equipment from the packaging system) Qiushan international, which completely replaces iso11607-2003 and EN868-1's understanding of MDSP, and the latter two have been staying at the concept of "initial packaging" or "basic packaging".
Another very important progress is that in Appendix B of this part, there are 34 kinds of test reference standards, 71 in total, which may be used to construct the "sterile barrier system (SBS)" or the functional experiment of the system itself, mainly including ISO, ASTM, en and ISTA. These standards are often used in MDSP design and practical verification, of course Some standards are not all, nor must they be complied with, because iso11607-2006 itself stipulates some self-made, not officially included tests