Home

Standards catalogue

Subscribe to updates

ISO/TC 198  - Sterilization of health care products

Items to be displayed:


Standards and projects under the direct responsibility of ISO/TC 198 Secretariat and its SCs

Standard and/or projectStageICSTC
ISO 11135:2014/CD Amd 1
30.99 11.080.01ISO/TC 198
ISO/DIS 11137-3
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects of development, validation and routine control
40.99 11.080.01ISO/TC 198
ISO/NP TS 11137-4
Sterilization of health care products -- Radiation -- Part 4: Guidance on process control
10.99ISO/TC 198
ISO/FDIS 11138-1
Sterilization of health care products -- Biological indicators -- Part 1: General requirements
50.00 11.080.01ISO/TC 198
ISO/FDIS 11138-2
Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
50.00 11.080.01ISO/TC 198
ISO/FDIS 11138-3
Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
50.00 11.080.01ISO/TC 198
ISO/FDIS 11138-4
Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes
50.00 11.080.01ISO/TC 198
ISO/FDIS 11138-5
Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
50.00 11.080.01ISO/TC 198
ISO/CD 11139
Sterilization of health care products -- Vocabulary
30.60 11.080.01
01.040.11
ISO/TC 198
ISO/CD 11140-6
Sterilization of health care products -- Chemical indicators -- Part 6: Class 2 indicators and process challenge devices for use in performance testing of steam sterilizers
30.92 11.080.01ISO/TC 198
ISO/NP 11607-1
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
10.99 11.080.30ISO/TC 198
ISO/NP 11607-2
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
10.99 11.080.30ISO/TC 198
ISO/DIS 11737-1
Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on product
40.00 11.080.01
07.100.10
ISO/TC 198
ISO/NP 11737-2
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
10.99 11.080.01
07.100.10
ISO/TC 198
ISO/CD 13408-2
Aseptic processing of health care products -- Part 2: Filtration
30.60 11.080.01ISO/TC 198
ISO/CD 14161
Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
30.20 11.080.01ISO/TC 198
ISO/NP 15883-1
Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests
10.99 11.080.10ISO/TC 198
ISO/DIS 15883-4
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
40.60 11.080.10ISO/TC 198
ISO/NP 15883-5
Washer disinfectors -- Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
10.99 11.080.10ISO/TC 198
ISO/CD 16342
Sterilization of health care products -- Biological indicators -- Method for validation of a biological indicator incubation period
30.20 11.080.01ISO/TC 198
ISO/DIS 17664
Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices
40.60 11.080.01ISO/TC 198
ISO/NP 17665-1
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
10.99 11.080.01ISO/TC 198
ISO/DIS 18472
Sterilization of health care products -- Biological and chemical indicators -- Test equipment
40.00 11.080.01ISO/TC 198
ISO/NP TS 19572
Sterilization of health care products -- Guidance on the application of ISO14937 to the sterilization of medical devices using Ethylene Oxide in a flexible sterilization chamber
10.99ISO/TC 198
ISO/WD TS 19930
Guidance on aspects of a risk-based approach to assuring sterility of terminally-sterilized, single-use health care products
20.60ISO/TC 198
ISO/NP TS 21387
Sterilization of medical devices -- Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
10.99ISO/TC 198
ISO/CD 25424
Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
30.99 11.080.01ISO/TC 198