ISO 11140-6:2022
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
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
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 40
- Дата публикации:
- 22 ноября 2022 г.
- Издание:
- ISO IS 11140 edition 1 version 1
- ICS:
- 11.080.01
This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060. NOTE The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities. a) Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for: — a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; — an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design. b) Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060). This document specifies the requirements for: — a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; — an alternative hollow device: — employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator; — equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.
Abstract
Overview
ISO 11140-6:2022 - "Sterilization of health care products - Chemical indicators - Part 6" defines Type 2 chemical indicators and process challenge devices (PCDs) for performance testing of small steam sterilizers (those conforming to EN 13060). The standard sets out performance requirements and test methods for two classes of PCDs used to assess steam penetration: porous devices and hollow (lumened) devices. It also defines how chemical indicators and biological indicators are used within these devices to judge adequacy of steam penetration in type B cycles and some type S cycles.
Key topics and technical requirements
- Scope and intended use: Devices and indicators are for performance testing of small steam sterilizers only; they are not surrogate medical devices for routine sterilization of hollow/porous medical instruments.
- Reference vs. alternative devices:
- Reference Porous Device (RPD) - a textile test pack with steam penetration judged thermometrically; used as a benchmark.
- Alternative Porous Indicator System (APIS) - commercially manufactured systems shown equivalent to the RPD by specified tests.
- Reference Hollow Device (RHD) - a lumened device with attached capsule judged by biological indicator inactivation/survival.
- Alternative Hollow Indicator System (AHIS) - chemical-indicator-based hollow devices validated to be equivalent to the RHD.
- Test methods and annexes: Normative test procedures are provided (e.g., performance tests for RHIS, APIS, AHIS; RHD construction; leakage and ageing evaluations).
- Operational requirements:
- Conditioning of indicators and devices at (25 ± 5) °C and (50 ± 10) % RH.
- Indicators must not transfer reagent to device materials in a way that impairs utility.
- Reusable PCDs must remain compliant when used according to instructions (including reuse limits, cleaning and maintenance).
- Marking and labelling: Requirements for device labelling and additional hollow-device specifics are specified.
Practical applications
- Performance testing and acceptance of small steam sterilizers (type B and select type S cycles).
- Validation and equivalence testing for suppliers developing alternative porous or hollow chemical indicator systems (APIS, AHIS).
- Quality assurance in sterile processing departments, biomedical engineering, and contract sterilization services to verify steam penetration.
- Test-lab procedures for interlaboratory evaluations and conformity testing of sterilization equipment.
Who should use ISO 11140-6:2022
- Sterilizer manufacturers and designers of small steam sterilizers (EN 13060).
- Manufacturers of chemical indicators, process challenge devices (PCDs) and biological indicators.
- Sterile processing departments, hospital quality managers, regulatory compliance teams, and independent test laboratories performing sterilizer performance testing.
Related standards
- ISO 11140-1 (general chemical indicator requirements)
- ISO 11138-3 (biological indicators for moist heat)
- ISO 11140-4 (Class 2 indicators / Bowie-Dick alternative)
- EN 13060 (small steam sterilizers) and EN 285 (large sterilizer testing) - referenced for cycle types and context
Keywords: ISO 11140-6:2022, small steam sterilizers, chemical indicators, process challenge devices, steam penetration, RPD, RHD, APIS, AHIS, type 2 indicators, EN 13060.
Технические детали
- Технический комитет
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 11140-6:2022
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