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CH/198 - Sterilization and Associated Equipment and Processes

Sector: Governance & Resilience

Categories: Chemical laboratories. Equipment | Thermosetting materials | Sacks. Bags | Piezoelectric devices | Hospital equipment | Sterilizing equipment | Pharmaceutics | Health care technology | Microbiology. General | Materials and articles in contact with foodstuffs | Sterilization and disinfection. Other | Sterilized packaging | Sterilization and disinfection | Sterilization and disinfection. General | Disinfectants and antiseptics | Laboratory | Boilers and heat exchangers | Dentistry. General | Paper and board | Testing. Electrical and electronic | Packaging materials and accessories | Wound dressings and compresses | Microbiology. Medical | Cans. Tins. Tubes

Overview: Under the direction of the Standards Policy & Strategy Committee, is responsible for the UK input into CEN/TC 102, CEN/TC 204, ISO/TC 198 and British Standards relating to sterilizers, autoclaves and disinfectors.

Committee standards activity

In Progress (51)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/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

Categories: Sterilization and disinfection. General

Drafting begins : 2017-05-06 		Drafting
PD ISO/TS 17664-3 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classification

Categories: Unclassified documents

Proposal begins : 		Proposal
ISO/TC 198 N 1607 Quality of water for sterilizers, sterilization and washer-disinfectors

Categories: Measurement and Science | Healthcare | Medical equipment | Sterilization and disinfection | Sterilization and disinfection. General | Sterilizing equipment | Disinfectants and antiseptics | Environment | Water quality | Water. Examination. Physical properties

Proposal begins : 2020-03-11 		Proposal
ISO/NP TS 25443 Sterilization of health care products — Moist heat — Guidance for verification of a process challenge device (PCD) to a specific load configuration

Categories: Information management | Standardization. General rules

Proposal begins : 2024-09-26 		Proposal
ISO/NP TS 17664-3 Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices -- Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classification

Categories: Information management | Standardization. General rules | Healthcare | Medical equipment | Sterilization and disinfection | Sterilizing equipment

Proposal begins : 2022-12-07 		Proposal
ISO/NP 25442 Sterilization of health care products — Test procedure for Measurement of temperature, pressure, and humidity in equipment

Categories: Information management | Standardization. General rules

Proposal begins : 2024-09-26 		Proposal
ISO/NP 25224 Sterilization of health care products — Sampling and culturing for reusable, thermolabile flexible endoscopes

Categories: Information management | Standardization. General rules

Proposal begins : 2024-05-10 		Proposal
ISO/NP 19253 Sterilization of health care products — Application of ISO/TS 22421 to the requirements for sterilizers used for the terminal sterilization of health care products containing aqueous liquid in sealed containers

Categories: Information management | Standardization. General rules | Healthcare | Sterilization and disinfection | Sterilization and disinfection. General

Proposal begins : 2022-10-14 		Proposal
draft Decision 540_Adoption of a NWI_ISO/NP 11138-6 Adoption of a NWI_ISO/NP 11138-6

Categories: Information management | Standardization. General rules

Proposal begins : 2024-04-25 		Proposal
CEN/TC 204 N 764, BS EN 556-1;2001 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE". Requirements for terminally sterilized medical devices

Categories: Information management | Standardization. General rules | Healthcare | Medical equipment | Sterilization and disinfection | Sterilizing equipment

Proposal begins : 2022-03-21 		Proposal
Published (81)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 5111:2022 Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products

Categories: Sterilization and disinfection. General

Published standard begins : 2023-01-17 		Published standard
PD ISO/TS 22456:2021 Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

Categories: Microbiology. Medical | Sterilization and disinfection. General

Published standard begins : 2021-03-22 		Published standard
PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

Categories: Sterilization and disinfection. General

Published standard begins : 2021-01-26 		Published standard
PD ISO/TS 21387:2020 Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

Categories: Sterilization and disinfection. General

Published standard begins : 2020-09-16 		Published standard
PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

Categories: Sterilization and disinfection. General

Published standard begins : 2017-12-01 		Published standard
PD CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

Categories: Sterilized packaging

Published standard begins : 2021-11-26 		Published standard
PD CEN ISO/TS 11137-4:2023 Sterilization of health care products. Radiation. Guidance on process control

Categories: Sterilization and disinfection. General

Published standard begins : 2023-06-23 		Published standard
BS ISO 22441:2022 Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

Categories: Sterilization and disinfection. General

Published standard begins : 2022-10-28 		Published standard
BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing

Categories: Sterilization and disinfection. General

Published standard begins : 2023-02-07 		Published standard
BS ISO 11737-3:2023 Sterilization of health care products. Microbiological methods. Bacterial endotoxin testing

Categories: Microbiology. Medical | Sterilization and disinfection. General

Published standard begins : 2023-06-28 		Published standard
Withdrawn (113)
Reference Standards description
Status ?

The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Categories: Sterilization and disinfection. General

Withdrawn begins : 2024-05-01 		Withdrawn
PD ISO/TS 13004:2013 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VD<sub>max</sub>SD

Categories: Sterilization and disinfection. General

Withdrawn begins : 2014-07-21 		Withdrawn
PD ISO/TS 11137-4:2020 Sterilization of health care products. Radiation. Guidance on process control

Categories: Sterilization and disinfection. General

Withdrawn begins : 2023-06-23 		Withdrawn
PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

Categories: Sterilized packaging

Withdrawn begins : 2021-11-26 		Withdrawn
PD CEN ISO/TS 13004:2014 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VD<sub>max</sub>SD

Categories: Sterilization and disinfection. General

Withdrawn begins : 2022-10-12 		Withdrawn
DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat. Guidance on the application of ISO 17665-1

Categories: Sterilization and disinfection. General

Withdrawn begins : 2024-05-01 		Withdrawn
DD CEN ISO/TS 11135-2:2008 Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1

Categories: Sterilization and disinfection. General

Withdrawn begins : 2011-09-16 		Withdrawn
BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing

Categories: Sterilization and disinfection. General

Withdrawn begins : 2023-02-07 		Withdrawn
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices

Categories: Sterilization and disinfection. General

Withdrawn begins : 2024-01-10 		Withdrawn
BS ISO 13408-7:2012 Aseptic processing of health care products. Alternative processes for medical devices and combination products

Categories: Sterilization and disinfection. General

Withdrawn begins : 2015-08-21 		Withdrawn