ISO 21171:2006

Name: ISO 21171:2006 — Medical gloves — Determination of removable surface powder
SKU: ISO 21171:2006
Price: 16200 RUB
Availability: InStock

Medical gloves — Determination of removable surface powder

Название (английский):

ISO 21171:2006

Medical gloves — Determination of removable surface powder

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 10 мая 2006 г.
Издание:: ISO IS 21171 edition 1 version 1
ICS:: 11.140

Тип поставки:

Full version16 200 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

Язык документа:

ruen

Срок поставки:2 раб. дн. (перевод)

Цена:16 200 ₽

Описание (английский):

ISO 21171:2006 specifies methods for the determination of readily removable powder on the surface of gloves for medical use. Three methods are specified: method A for powdered gloves and methods B and C for powder-free gloves. This International Standard does not address safety issues that may be associated with the presence of powder on gloves nor does it prescribe limits on the amounts that may be present. The applicability of this International Standard to medical gloves not made from rubber has not been established.

Abstract

Похожие стандарты

Другие стандарты ISO

Overview

ISO 21171:2006 - Medical gloves - Determination of removable surface powder specifies laboratory methods to quantify readily removable, water‑insoluble powder on the surface of medical gloves. It defines three test procedures: Method A for powdered gloves and Methods B and C for powder‑free gloves (with Method C tailored for surgeon’s gloves). The standard describes sampling, apparatus, reagents and calculation procedures but does not prescribe safety limits or address safety issues related to glove powder. Applicability to non‑rubber medical gloves is not established.

Key topics and technical requirements

Scope and definitions: Defines “powder” as the water‑insoluble material removed under test conditions and distinguishes powdered vs. powder‑free gloves.

Sampling: Random selection; Method A uses two gloves, Method B uses five gloves, Method C uses three pairs (six gloves) for surgeon’s gloves.

Test principle: Surfaces are washed with water to transfer removable powder to the rinse water; powder is collected by filtration, dried and weighed.

Apparatus & critical parameters:

Balance accuracy: 0.1 mg
Mechanical shaker: minimum 1.7 Hz (102 cycles/min) for 30 s washes
Drying oven: 100 °C ± 5 °C
Filters: glass microfibre filters 2.7 µm pore size - 90 mm for Method A; 47 mm for Methods B/C

Procedure highlights:

Multiple rinses per glove (four rinses for Method A); pooled rinses for Methods B/C
Blank determinations required for powder‑free procedures to account for background contamination
Calculation formulas to report total and average powder mass per glove (mg)

Quality elements: Clauses on precision and test reporting are included in the standard.

Applications and practical value

Quality control and batch testing for medical glove manufacturers to verify product consistency and labelling (powdered vs. powder‑free).

Independent testing laboratories performing routine or compliance testing using standardized, reproducible methods.

Procurement, regulatory and hospital QA teams that require documented test results to support acceptance criteria, supplier evaluation or comparative assessments.

Useful for research into glove manufacturing processes and for investigations where quantifying removable surface powder is needed.

ISO 21171:2006

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and practical value

Related standards

Технические детали

ISO 8689-1:2000

Water quality — Biological classification of rivers — Part 1: Guidance on the interpretation of biological qu…

ISO/ASTM51540-04(2012)

Standard Practice for Use of a Radiochromic Liquid Dosimetry System (Withdrawn 2020)

ISO/ASTM51204-04

Standard Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing (Withdrawn 2013)

ISO/ASTM51431-05

Standard Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food P…

ISO/ASTM52628-20e1

Standard Practice for Dosimetry in Radiation Processing

ISO/ASTM52921-13(2019)

Standard Terminology for Additive Manufacturing—Coordinate Systems and Test Methodologies

ISO/ASTMTR52917-EB

Additive Manufacturing — Round Robin Testing — General Guidelines

ISO/ASTM52901-17(2023)

Standard Guide for Additive Manufacturing – General Principles – Requirements for Purchased AM Parts