ISO 10993-7:2008 PDF

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

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Название (английский):

ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 86
Дата публикации:: 13 октября 2008 г.
Издание:: ISO IS 10993 edition 2 version 1
ICS:: 11.100.20

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Срок поставки:15 раб. дн. (перевод)

Цена:1 290 €

Описание (английский):

ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

Технические детали

Технический комитет: ISO/TC 194 - Biological and clinical evaluation of medical devices
SKU: ISO 10993-7:2008

Abstract

Overview

ISO 10993-7:2008 - "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals" defines how to assess and control residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO‑sterilized medical devices. The standard specifies allowable limits, measurement procedures, and product‑release methods so that EO‑sterilized devices with patient contact can be released safely. Devices with no patient contact (e.g., many in vitro diagnostic devices) are excluded. Ethylene glycol (EG) is discussed but no device limits are specified.

Key topics and technical requirements

Allowable limits: Devices are categorized by duration of contact (limited A, prolonged B, permanent C). Example limits:
- Permanent contact (C): EO average daily dose ≤ 0.1 mg/day; maximum EO 4 mg (first 24 h), 60 mg (first 30 d), 2.5 g (lifetime). ECH average daily ≤ 0.4 mg/day; corresponding early‑use and lifetime caps apply.
- Prolonged exposure (B): EO average daily ≤ 2 mg/day; maximum EO 4 mg (24 h), 60 mg (30 d). ECH average daily ≤ 2 mg/day; ECH early caps apply.
Measurement methods: Procedures for gas chromatographic determination of EO and ECH are provided (normative and informative annexes). Extraction techniques are defined, including simulated‑use extraction and exhaustive extraction criteria.
Product release and compliance: Methods include use of residue dissipation curves, release procedures with/without dissipation data, and guidance for interpreting chromatograms and establishing compliance.
Risk basis: Limits are established to protect against systemic and local effects (e.g., irritation, mutagenicity considerations) and are intended to be used alongside the broader biological evaluation in ISO 10993‑1.

Applications and users

Who uses it: medical device manufacturers, sterilization engineers, quality assurance, regulatory affairs professionals, testing laboratories, and clinical safety assessors.
Practical uses:

Abstract

Overview

Key topics and technical requirements

Allowable limits: Devices are categorized by duration of contact (limited A, prolonged B, permanent C). Example limits:
- Permanent contact (C): EO average daily dose ≤ 0.1 mg/day; maximum EO 4 mg (first 24 h), 60 mg (first 30 d), 2.5 g (lifetime). ECH average daily ≤ 0.4 mg/day; corresponding early‑use and lifetime caps apply.
- Prolonged exposure (B): EO average daily ≤ 2 mg/day; maximum EO 4 mg (24 h), 60 mg (30 d). ECH average daily ≤ 2 mg/day; ECH early caps apply.
Measurement methods: Procedures for gas chromatographic determination of EO and ECH are provided (normative and informative annexes). Extraction techniques are defined, including simulated‑use extraction and exhaustive extraction criteria.
Product release and compliance: Methods include use of residue dissipation curves, release procedures with/without dissipation data, and guidance for interpreting chromatograms and establishing compliance.
Risk basis: Limits are established to protect against systemic and local effects (e.g., irritation, mutagenicity considerations) and are intended to be used alongside the broader biological evaluation in ISO 10993‑1.

Applications and users

Who uses it: medical device manufacturers, sterilization engineers, quality assurance, regulatory affairs professionals, testing laboratories, and clinical safety assessors.
Practical uses:

ISO 10993-7:2008 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Applications and users

Abstract

Overview

Key topics and technical requirements

Applications and users

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