ISO 8600-8:2021 PDF
Endoscopes — Medical endoscopes and endotherapy devices — Part 8: Particular requirements for capsule endoscopes
Endoscopes — Medical endoscopes and endotherapy devices — Part 8: Particular requirements for capsule endoscopes
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 14 мая 2021 г.
- Издание:
- ISO IS 8600 edition 1 version 1
- ICS:
- 11.040.55
This document applies to capsule endoscopes used for clinical practice. The document defines relevant terms and gives requirements for them.
Abstract
Overview - ISO 8600-8:2021 (Capsule endoscopes)
ISO 8600-8:2021 is the ISO part that sets used in clinical practice. It defines key terms (maximum diameter, maximum length, recording time) and specifies product requirements, testing, marking, instruction content and packaging expectations for capsule-shaped medical endoscopes. The standard supports safe design, consistent testing and clear labeling of capsule endoscopes for manufacturers, test laboratories and healthcare providers.
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