ISO 11139:2018
Current
Current
The latest, up-to-date edition.
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
English, French
Published date
03-08-2018
£41.00
Excluding VAT
This document defines terms in the field of the sterilization of health care products including related equipment and processes.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
48
|
| ProductNote |
THIS STANDARD ALSO REFERES TO:ISO/TS WD 11137-4,ISO/CD 11138‑8:2016,ISO/FDIS 11607‑1:2018,ISO/FDIS 11607‑2:2018,ISO/FDIS 15883‑4:2018,ISO/FDIS 15883‑5:2018,ISO/CD 5883‑5:2017,ISO/DTS 19572:2018,ISO/DTS 1387:2018,ISO/FDIS 25424:2018,IEC 61010‑2‑040:2015,EN 285:2015 + prA1:2018,EN 556‑1:2001,EN 764‑1:2004,GHTF/SG1/N055:2009,GHTF/SG3/N99-10:2004
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ABNT NBR ISO 11139:2023 | Identical |
| IS 18240 : 2023 | Identical |
| NEN-EN-ISO 11139 : 2018 | Identical |
| SS-EN ISO 11139:2018 | Identical |
| NEN ISO 11139 : 2018 | Identical |
| NF EN ISO 11139 September 2018 | Identical |
| I.S. EN ISO 11139:2018&LC:2018 | Identical |
| PN-EN ISO 11139 : 2018 | Identical |
| EN ISO 11139:2018 | Identical |
| BS EN ISO 11139:2018 | Identical |
| DS/EN ISO 11139:2018 | Identical |
| UNE-EN ISO 11139:2020 | Identical |
| DIN EN ISO 11139:2019-05 | Identical |
| NASA-STD-8719.27:2022 | IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT |
| ANSI/AAMI/ISO 11607-1:2019 | Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems<br> |
| AAMI/ISO TIR21387:2023 | Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release |
| ANSI/AAMI/ISO 13408-1:2023 | Aseptic processing of health care products—Part 1: General requirements |
| I.S. EN ISO 11737-2:2020 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) |
| ANSI/AAMI/ISO 13004:2022 | Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD |
| I.S. EN 556-1:2024 | Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices |
| I.S. EN 17141:2020 | Cleanrooms and associated controlled environments - Biocontamination control |
| ANSI/AAMI/ISO 18472:2022 | Sterilization of health care products—Biological and chemical indicators—Test equipment |
| AAMI/ISO TIR16775:2023 | Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ANSI/AAMI/ISO 17664-1:2022 | Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices |
| ANSI/AAMI/ISO 11140-6:2024 | Sterilization of health care products— Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers |
| AS 2773:2019 | Ultrasonic cleaners for health service organisations |
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