Sterilization of health care products : general requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009).
Saved in:
| Published: |
London :
BSI Group,
2010.
|
|---|---|
| Online Access: | |
| Corporate Authors: | |
| Series: | B.S. (Series) ;
BS EN ISO 14937:2009. European standard ; EN ISO 14937:2009. International standard ; ISO 14937:2009. |
| Format: | Electronic eBook |
MARC
| LEADER | 00000nam a22000005 4500 | ||
|---|---|---|---|
| 001 | 3188244 | ||
| 005 | 20221005095100.0 | ||
| 006 | m fo d | ||
| 007 | cr bn#---auuu | ||
| 008 | 221005t20102010enk ou 000 0 eng | ||
| 020 | |a 9780580578502 | ||
| 040 | |a CU |b eng |e rda |c CU | ||
| 043 | |a e-uk--- | ||
| 097 | |3 Bib#: |a 3188244 | ||
| 110 | 2 | |a British Standards Institution. |e author, |e issuing body. | |
| 245 | 1 | 0 | |a Sterilization of health care products : |b general requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009). |
| 246 | 1 | |i At the head of title: |a British Standard | |
| 246 | 3 | 0 | |a General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| 246 | 1 | 0 | |a BS EN ISO 14937:2009 |
| 246 | 1 | 0 | |a BS EN ISO 14937 |
| 246 | 1 | 0 | |a EN ISO 14937:2009 |
| 246 | 1 | 0 | |a ISO 14937:2009 |
| 264 | 1 | |a London : |b BSI Group, |c 2010. | |
| 264 | 4 | |c ©2010 | |
| 300 | |a 1 online resource (vii, 37 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a text file |2 rdaft | ||
| 347 | |b PDF | ||
| 490 | 1 | |a British standard ; |v BS EN ISO 14937:2009 | |
| 490 | 1 | |a European standard ; |v EN ISO 14937:2009 | |
| 490 | 1 | |a International standard ; |v ISO 14937:2009 | |
| 500 | |a "ICS 11.080.01" | ||
| 500 | |a "This British Standard is the UK implementation of EN ISO 14937:2009. It supersedes BS EN ISO 14937:2001 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices"--National foreword. | ||
| 500 | |a "This document (EN ISO 14937:2009) has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI ... This document supersedes EN ISO 14937:2000"--European foreword. | ||
| 500 | |a "ISO 14937 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 14937:2000) and ISO 14937:2000/Cor.1:2003 which have been technically revised"--International foreword. | ||
| 504 | |a Includes bibliographic references. | ||
| 520 | 0 | |a "This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products. 1.1.2. This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. 1.1.3. This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. 1.1.4. This International Standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process."--Scope. | |
| 710 | 2 | |a British Standards Institution. |b Technical Committee CH/198, Sterilization of medical devices, |e author. | |
| 710 | 2 | |a European Committee for Standardization. |b Technical Committee CEN/TC 204 “Sterilization of medical devices”, |e author. | |
| 710 | 2 | |a Technical Committee ISO/TC 198, Sterilization of health care products, |e author. | |
| 710 | 2 | |a European Committee for Standardization, |e author, |e issuing body. | |
| 710 | 2 | |a International Organization for Standardization. |e author, |e issuing body. | |
| 830 | 0 | |a B.S. (Series) ; |v BS EN ISO 14937:2009. | |
| 830 | 0 | |a European standard ; |v EN ISO 14937:2009. | |
| 830 | 0 | |a International standard ; |v ISO 14937:2009. | |
| 856 | 4 | 0 | |u https://go.openathens.net/redirector/canterbury.ac.nz?url=https://bsol.bsigroup.com/Bibliographic/BibliographicInfoData/000000000030157762 |y Connect to electronic resource |t 0 |
| 945 | |b DO NOT SET |c Manual | ||
| 991 | |a 2022-09-27 | ||
| 992 | |a Created by sico, 27/09/2022. Updated by lisa, 05/10/2022. | ||
| 999 | f | f | |i dbc78a3c-80bc-5251-af98-bf52d60754c6 |s c6ac9a58-67d5-56f4-b52c-d717d34708f7 |t 0 |
