ISO 15883-2:2024 PDF

Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices

Первая страница стандарта ISO 15883-2:2024

Открыть превью (PDF)

Название (английский):

ISO 15883-2:2024

Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 6 ноября 2024 г.
Издание:: ISO IS 15883 edition 2 version 1
ICS:: 11.080.10

Язык документа:

ruen

Срок поставки:3 раб. дн. (перевод)

Цена:210 €

Описание (английский):

This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware. This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1. NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

Технические детали

Технический комитет: ISO/TC 198 - Sterilization of health care products
SKU: ISO 15883-2:2024

Abstract

Overview

ISO 15883-2:2024 - "Washer‑disinfectors - Part 2" specifies requirements and test methods for washer‑disinfectors (WD) that use thermal disinfection to process reusable critical and semi‑critical medical devices (for example, surgical instruments, anaesthetic equipment, and associated non‑critical items such as bowls and glassware). It is the second edition, intended to be used together with the general requirements in ISO 15883‑1:2024. The standard clarifies performance, verification and testing for cleaning and thermal disinfection in a single operating cycle and notes that it does not guarantee removal/inactivation of prion agents.

Key topics and technical requirements

Scope and device types: Applies to critical and semi‑critical medical devices, powered instruments, anaesthetic/respiratory equipment and non‑critical items used with them.
Performance requirements: Specifies cleaning and thermal disinfection performance criteria (soil removal, maintained process variables, and limitations related to prions).
Temperature control and thermometry: Requirements and tests for temperature of device outer and inner surfaces, and for defining and verifying the washing temperature band. (The 2024 revision adjusted the washing temperature band limit.)
Lumen and powered device handling: Special requirements for irrigation, flow verification through lumens and verification of powered devices.
Water quality: New clause addressing water quality requirements relevant to cleaning/disinfection performance and environmental/regulatory impacts.
Mechanical and control systems: Requirements for control systems, dosing accuracy (noting certain exceptions), process monitoring and verification.
Testing for conformity: Defined test programmes for soil removal, thermometric tests, pressure and flow measurements and worst‑case validation.
Documentation: Information the WD supplier must provide and information purchasers should request; Annex B gives guidance on assigning devices to product families for processing.

Practical applications - who uses this standard

Manufacturers of washer‑disinfectors - to design, validate and document compliance for thermal WD models.
Sterile Processing Departments (SPD) in hospitals and clinics - to select appropriate WD cycles and validate processes for surgical and semi‑critical devices.
Medical device manufacturers - to provide processing instructions consistent with ISO 17664 series and align device families for WD processing.
Test laboratories and conformity assessors - to run the standardized test programmes for performance verification.
Regulators and procurement specialists - to specify requirements in purchasing and compliance frameworks.

Related standards

ISO 15883‑1:2024 (general requirements)
ISO 15883‑5:2021 (cleaning efficacy criteria)
ISO 17664‑1:2021 (processing information from device manufacturers)
IEC 61010‑2‑040 (safety requirements for WD)
ISO 11139 (terms and definitions referenced)

Keywords: ISO 15883‑2:2024, washer‑disinfectors, thermal disinfection, critical medical devices, semi‑critical devices, cleaning efficacy, lumen irrigation, process verification.

Overview

Key topics and technical requirements

Scope and device types: Applies to critical and semi‑critical medical devices, powered instruments, anaesthetic/respiratory equipment and non‑critical items used with them.
Performance requirements: Specifies cleaning and thermal disinfection performance criteria (soil removal, maintained process variables, and limitations related to prions).
Temperature control and thermometry: Requirements and tests for temperature of device outer and inner surfaces, and for defining and verifying the washing temperature band. (The 2024 revision adjusted the washing temperature band limit.)
Lumen and powered device handling: Special requirements for irrigation, flow verification through lumens and verification of powered devices.
Water quality: New clause addressing water quality requirements relevant to cleaning/disinfection performance and environmental/regulatory impacts.
Mechanical and control systems: Requirements for control systems, dosing accuracy (noting certain exceptions), process monitoring and verification.
Testing for conformity: Defined test programmes for soil removal, thermometric tests, pressure and flow measurements and worst‑case validation.
Documentation: Information the WD supplier must provide and information purchasers should request; Annex B gives guidance on assigning devices to product families for processing.

Practical applications - who uses this standard

Manufacturers of washer‑disinfectors - to design, validate and document compliance for thermal WD models.
Sterile Processing Departments (SPD) in hospitals and clinics - to select appropriate WD cycles and validate processes for surgical and semi‑critical devices.
Medical device manufacturers - to provide processing instructions consistent with ISO 17664 series and align device families for WD processing.
Test laboratories and conformity assessors - to run the standardized test programmes for performance verification.
Regulators and procurement specialists - to specify requirements in purchasing and compliance frameworks.

Related standards

ISO 15883‑1:2024 (general requirements)
ISO 15883‑5:2021 (cleaning efficacy criteria)
ISO 17664‑1:2021 (processing information from device manufacturers)
IEC 61010‑2‑040 (safety requirements for WD)
ISO 11139 (terms and definitions referenced)

Keywords: ISO 15883‑2:2024, washer‑disinfectors, thermal disinfection, critical medical devices, semi‑critical devices, cleaning efficacy, lumen irrigation, process verification.

ISO 15883-2:2024 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards

Похожие стандарты

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests

Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning ef…

Processing of health care products — Information to be provided by the medical device manufacturer for the pr…

Processing of health care products - Information to be provided by the medical device manufacturer for the pr…

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Parti…

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and p…