ISO 1135-3:2016 PDF

Name: ISO 1135-3:2016 — Transfusion equipment for medical use — Part 3: Blood-taking sets for single use
SKU: ISO 1135-3:2016
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Transfusion equipment for medical use — Part 3: Blood-taking sets for single use

Название (английский):

ISO 1135-3:2016

Transfusion equipment for medical use — Part 3: Blood-taking sets for single use

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 21 октября 2016 г.
Издание:: ISO IS 1135 edition 2 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 1135-3:2016 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only. ISO 1135-3:2016 also aims to provide a) specifications relating to the quality and performance of materials used in transfusion equipment, and b) a unified presentation of terms for such equipment. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-3:2016.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 1135-3:2016 - "Transfusion equipment for medical use - Part 3: Blood-taking sets for single use" defines requirements for sterilized, single‑use blood‑taking sets to ensure functional interchangeability of transfusion equipment. The standard covers design, materials, sterilization, physical/chemical/biological performance, labelling, packaging and disposal. It is intended to harmonize terminology and define testable criteria so manufacturers, regulators and users can trust compatibility and safety of blood‑collection sets.

Key topics and technical requirements

Scope and intent

Applies to sterilized blood‑taking sets intended for single use only.
Aims to specify material quality/performance and unify terms; national regulations or pharmacopoeias may take precedence.

Component definitions

Two main assemblies: blood‑taking assembly (blood‑taking needle + bottle needle + tubing) and air‑outlet assembly (air filter housing + air‑outlet needle).
Protective caps required to preserve sterility of needles and internal surfaces.

Physical requirements

Minimize particulate contamination; surfaces of fluid pathways must be smooth and clean (particulate limits and test procedures in Annex A).
No air leakage; connections (excluding caps) must withstand a static tensile force ≥ 15 N for 15 s.
Dimensional and performance limits:
- Bottle needle: length ≥ 35 mm, external diameter ≥ 1.8 mm, internal diameter ≥ 70% of external.
- Blood‑taking needle: length ≥ 35 mm, external diameter ≤ 2 mm, internal diameter ≥ 70% of external.
- Air‑outlet needle: internal diameter ≥ 0.7 mm, external diameter ≤ 1.9 mm, length ≤ 25 mm.
- Tubing: internal diameter ≥ 2.7 mm, length ≥ 600 mm, flexible and kink‑resistant.
Flow regulator must adjust flow from zero to maximum and withstand continuous use without damaging tubing.

Chemical and biological

Chemical extractables limits (e.g., reducing matter and metal ion limits - see Annex B).
Biological requirements include sterility, pyrogenicity, haemolysis and toxicity testing (Annex C).

Sterilization & packaging

Sets must be sterile in the unit container with evidence of sterilization process effectiveness; packaging guidance aligns with ISO 11607.

Labelling & disposal

Requirements for unit and multi‑unit labelling; Clause added on disposal of single‑use sets.

Applications and users

Manufacturers of blood‑taking and transfusion equipment - for design, testing and regulatory compliance.

Quality assurance / regulatory affairs teams - to implement normative tests and documentation.

Hospitals, blood banks and transfusion services - to select compatible, safe single‑use collection sets.

Test laboratories - to execute the physical, chemical and biological test methods specified in the annexes.

Procurement specialists - for specification of interoperable blood‑collection products.

Related standards (selected)

ISO 7864 - Sterile hypodermic needles for single use

ISO 11607‑1 - Packaging for terminally sterilized medical devices

ISO 14644‑1 - Cleanroom classification

ISO 15223‑1 - Symbols on medical device labelling

Keywords: ISO 1135-3:2016, blood‑taking sets, transfusion equipment, single‑use, sterilization, tubing, needles, flow regulator, biocompatibility, medical device standards.

ISO 1135-3:2016 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards (selected)

Технические детали

ISO 11607-2:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing an…

SIST EN ISO 7864:2016

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

ISO 11607-1:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier sys…

BS EN ISO 14644-13:2026

Cleanrooms and associated controlled environments. Cleaning of surfaces to achieve defined levels of cleanlin…

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…