ISO 7886-2:2020 PDF

Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps

Название (английский):

ISO 7886-2:2020

Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 24 апреля 2020 г.
Издание:: ISO IS 7886 edition 2 version 1
ICS:: 11.040.25

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Описание (английский):

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

Технические детали

Технический комитет: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 7886-2:2020

Abstract

Overview

ISO 7886-2:2020 specifies requirements for sterile single‑use hypodermic syringes (nominal capacity 1 ml and above) made of plastic and intended for use with power‑driven syringe pumps. It defines design, dimensional and performance requirements, test methods and information that manufacturers must supply. The standard excludes auto‑disable syringes (ISO 7886‑3), insulin syringes (ISO 8537), glass syringes, prefilled syringes and pharmacist‑fill kits, and it does not address compatibility with injection fluids.

Key topics and technical requirements

Scope and exclusions: Plastic, single‑use syringes ≥1 ml for power‑driven pumps; several syringe types explicitly excluded.
Design and nomenclature: Requirements for barrel, nozzle, piston/plunger assemblies and overall syringe geometry (see Clause 11–13).
Performance tests (Clause 14 and normative Annexes):
- Dead space - limits on residual volume.
- Leakage - freedom from air and liquid leakage past the plunger stopper.
- Short‑term flow‑rate accuracy - test methods and acceptance criteria (Annex A).
- Pump forces - measurement guidance (Annex B).
- Syringe compliance - determination procedures (Annex C).
Material and chemical limits: Acidity/alkalinity, extractable metals, and lubricant considerations (Clauses 6–8).
Graduated scale and tolerance: Marking, scale accuracy and capacity tolerances (Clauses 9–10).
Packaging and labelling: Unit, multiple‑unit and user packaging, plus mandatory manufacturer information and marking (Clauses 15–16).
Test methodology notes: Recognizes gravimetric limits at very low flow rates (speeds

Overview

Key topics and technical requirements

Scope and exclusions: Plastic, single‑use syringes ≥1 ml for power‑driven pumps; several syringe types explicitly excluded.
Design and nomenclature: Requirements for barrel, nozzle, piston/plunger assemblies and overall syringe geometry (see Clause 11–13).
Performance tests (Clause 14 and normative Annexes):
- Dead space - limits on residual volume.
- Leakage - freedom from air and liquid leakage past the plunger stopper.
- Short‑term flow‑rate accuracy - test methods and acceptance criteria (Annex A).
- Pump forces - measurement guidance (Annex B).
- Syringe compliance - determination procedures (Annex C).
Material and chemical limits: Acidity/alkalinity, extractable metals, and lubricant considerations (Clauses 6–8).
Graduated scale and tolerance: Marking, scale accuracy and capacity tolerances (Clauses 9–10).
Packaging and labelling: Unit, multiple‑unit and user packaging, plus mandatory manufacturer information and marking (Clauses 15–16).
Test methodology notes: Recognizes gravimetric limits at very low flow rates (speeds

ISO 7886-2:2020 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

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Abstract

Overview

Key topics and technical requirements

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