Natural rubber latex cleanroom gloves - Specification

ISO 20437:2017 gives the specification for ISO 4, ISO 5 and ISO 6 cleanroom gloves. It is applicable to cleanroom gloves made of natural rubber latex (NRL).

Gants pour salle blanche en latex de caoutchouc naturel - Spécifications

General Information

Status
Published
Publication Date
26-Jul-2017
Current Stage
9093 - International Standard confirmed
Start Date
29-Oct-2022
Completion Date
13-Dec-2025

Relations

Effective Date
06-Jun-2022

Overview

ISO 20437:2017 specifies requirements for natural rubber latex (NRL) cleanroom gloves designed for use in highly controlled cleanroom environments classified as ISO 4, ISO 5, and ISO 6. These gloves are critical for minimizing contamination in industries where pollution control is paramount-such as electronics, semiconductors, thin-film transistor (TFT) manufacturing, liquid crystal display (LCD) production, nanotechnology, and biomedical sectors.

The standard focuses on ensuring glove surfaces are free from contaminants such as submicron particles, ionic residues, total non-volatile residue (TNVR), and prohibited substances like silicone, amides, and dioctyl phthalate (DOP). By adhering to this specification, manufacturers and users can maintain the highest cleanroom integrity during product handling and processing.

Key Topics

Classification and Scope

  • Specifies cleanroom gloves compliant with ISO Classes 4, 5, and 6.
  • Applicable only to gloves made from natural rubber latex (NRL).

Contamination Control Parameters

Glove surfaces are controlled for:

  • Particle count: Limits on submicron particles released by gloves, essential to prevent airborne contamination.
  • Ionic content: Strict thresholds on ions such as fluoride, chloride, nitrate, sulfate, sodium, potassium, calcium, and magnesium to avoid chemical contamination.
  • Total Non-Volatile Residue (TNVR): Measurement of residual organic and inorganic substances on glove surfaces.
  • Silicone, Amide, DOP content: These substances must be absent to protect sensitive manufacturing processes.

Sampling and Testing

  • Sampling requires three gloves per batch per test parameter, ensuring statistically relevant data.
  • Test methods are aligned with IEST RP-CC005.4 protocols covering particle counting, ionic content analysis, TNVR, and detection of silicone, amide, and DOP.
  • Particle counts are segmented by size ranges from 0.5 to >20 micrometers for detailed contamination assessment.

Processing and Packaging

  • Gloves undergo submicron laundry processing using reverse osmosis deionized (RO-DI) water with resistivity between 13 and 18 megaohms to remove contaminants effectively.
  • Cleaned gloves are dried in specialized low-particle dryers within certified cleanroom environments with laminar airflow.
  • Packaging utilizes non-particulating materials with careful marking instructions to prevent exposure to heat or light, reducing further particle generation.

Applications

ISO 20437:2017 certified natural rubber latex cleanroom gloves are widely used where stringent contamination control is essential, including:

  • Semiconductor fabrication: Protecting ultra-pure wafers and chips from particulate and chemical contaminants.
  • Electronic and disk drive manufacturing: Avoiding contamination that can damage sensitive electronic components.
  • Display technology industries: TFT and LCD production requiring ultra-clean environments for manufacturing thin films and displays.
  • Nanotechnology and biomedical fields: Ensuring sterile, particle-free handling environments vital for high-precision and clinical applications.

Using gloves conforming to ISO 20437 enhances product quality, reduces defect rates, and ensures compliance with cleanroom regulations, thereby safeguarding critical manufacturing processes.

Related Standards

ISO 20437 references and aligns with several key standards for comprehensive cleanroom and glove quality management:

  • IEST RP-CC005.4: Standard test methods for gloves in controlled environments, detailing particle count and chemical residue evaluation.
  • ISO 14644-1 & ISO 14644-6: Classification and vocabulary standards for cleanrooms and associated controlled environments, providing the framework for environmental cleanliness levels.
  • ISO 11193-1: Specification for single-use medical examination gloves, complementing cleanroom glove standards in hygiene-critical fields.
  • ISO 2859-1: Sampling procedures that guide statistical acceptance in manufacturing quality control.

Adhering to ISO 20437 along with these standards ensures an integrated approach to contamination control, glove performance, and cleanroom compatibility.


By implementing ISO 20437:2017 specifications, manufacturers and users of natural rubber latex cleanroom gloves uphold the stringent quality and cleanliness required in critical cleanroom operations, thereby optimizing product integrity and process safety.

Standard

ISO 20437:2017 - Natural rubber latex cleanroom gloves -- Specification

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Frequently Asked Questions

ISO 20437:2017 is a standard published by the International Organization for Standardization (ISO). Its full title is "Natural rubber latex cleanroom gloves - Specification". This standard covers: ISO 20437:2017 gives the specification for ISO 4, ISO 5 and ISO 6 cleanroom gloves. It is applicable to cleanroom gloves made of natural rubber latex (NRL).

ISO 20437:2017 gives the specification for ISO 4, ISO 5 and ISO 6 cleanroom gloves. It is applicable to cleanroom gloves made of natural rubber latex (NRL).

ISO 20437:2017 is classified under the following ICS (International Classification for Standards) categories: 83.140.99 - Other rubber and plastics products. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 20437:2017 has the following relationships with other standards: It is inter standard links to ISO 11610:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ISO 20437:2017 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


INTERNATIONAL ISO
STANDARD 20437
First edition
2017-07
Natural rubber latex cleanroom
gloves — Specification
Gants pour salle blanche en latex de caoutchouc naturel -
Spécifications
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3  Terms and definitions . 1
4  Classification . 2
5 Requirements . 2
6 Sampling . 3
7 Test methods . 3
7.1 Particle count . 3
7.2 Ionic content . 3
7.3 Total non-volatile residue (TNVR) . 3
7.4 Silicone, amide and DOP content . 3
8 Processing, packaging and marking . 4
Bibliography . 5
Foreword
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This document was prepared by Technical Committee ISO/TC 45, Rubber and rubber products,
Subcommittee SC 4, Products (other than hoses).
iv © ISO 2017 – All rights reserved

Introduction
Cleanroom gloves have long been used in the critical environments of the electronic, disk drive,
semiconductor, as well as storage media industries. The quest for a cleaner glove, in new emerging
industries of thin-film transistor (TFT), liquid-crystal display (LCD), nanotechnology, bio-medical
applications, has ensured that this is a growing market.
The basic function of cleanroom gloves is to ensure minimal transfer of contaminants onto the products
or components being processed or manufactured in a clean environment. Such contaminants will
always be present in the exposed hands of the personnel. It is for this purpose that the hands need to be
gloved. However, such gloves must have minimal contaminants on its surface, thus the need for the use
of cleanroom gloves.
The principal contaminants that could compromise the quality or the integrity of the product or process
in a critical environment are submicron particles, ionic chemical contaminants, non-volatile chemical
components, as well as silicone, amide or dioctyl phthalate (DOP). In the cleanroom industry, these
parameters are known as particle count, ionic content, total non-volatile residue (TNVR) and silicone,
amide or DOP content.
Depending on the criticality of the operational environment, the appropriate cleanroom glove will need
to be used. Hence, a very crit
...

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