ISO 23464:2020

Overview

ISO 23464:2020 is an international standard specifying requirements for nitrile cleanroom gloves used in controlled environments. Applicable to acrylonitrile butadiene-based gloves, this document covers ISO Class 4, Class 5, and Class 6 gloves-designed to minimize contamination risks in critical cleanrooms. Published by ISO in 2020, this standard supports industries requiring stringent contamination control such as electronics, semiconductors, nanotechnology, and biomedical fields.

Cleanroom gloves certified to ISO 23464:2020 ensure minimal transfer of sub-micron particles, ionic contaminants, and chemical residues onto sensitive products or components, preserving the integrity and quality within controlled operations.

Key Topics

• Cleanroom Classification
  Defines three glove classes based on cleanliness levels:

  • ISO Class 4 (highest cleanliness)
  • ISO Class 5
  • ISO Class 6 (standard protection)

• Contaminant Limits
  The standard sets quantitative limits for glove parameters, including:

  • Particle counts per cm² on glove surfaces
  • Ionic chemical content (fluoride, chloride, bromide, nitrate, phosphate, sulfate, sodium, magnesium, potassium)
  • Total non-volatile residue (TNVR)
  • Absence of silicone, amide, and dioctyl phthalate (DOP)

• Testing and Sampling Methods
  Specifies sampling of 3 gloves per batch and defines test methods based on IEST-RP-CC005.4:2013 procedures for:

  • Particle counting across multiple size ranges (0.5 µm to >20 µm)
  • Ionic and TNVR chemical analysis
  • Detection of prohibited contaminants such as silicone and DOP

• Glove Processing and Packaging
  Requirements for cleanroom-compatible processing including laundering with high purity RO-DI water, extraction, drying under laminar airflow, and packaging in non-particulating materials to prevent contamination post-manufacture.

Applications

ISO 23464:2020 certified nitrile cleanroom gloves are critical in environments that demand ultra-clean conditions to avoid product contamination and process failures, including:

• Semiconductor Manufacturing
  Protects wafers and chips from particle and chemical contamination during fabrication stages.

• Electronic & Storage Media Industries
  Ensures integrity of sensitive components such as disk drives and flat panel displays.

• Nanotechnology & TFT/LCD Production
  Provides ultra-clean handling for nano-scale components and advanced display technologies.

• Biomedical and Pharmaceutical Processing
  Maintains aseptic conditions by controlling glove particulates and chemical residues in critical healthcare and research labs.

• Cleanroom Laboratory Operations
  Supports environments classified under ISO 14644 for air cleanliness, reducing airborne and surface contamination sources.

Related Standards

• ISO 14644-1: Classification of air cleanliness by particle concentration, relevant for cleanroom environment control.
• IEST-RP-CC005.4:2013: Recommended practices for cleanroom gloves and finger cots, referenced for testing methods.
• ISO 2859-1: Sampling procedures for inspection by attributes, guiding batch testing approaches.
• ISO 11193-1: Specification for single-use medical examination gloves, providing complementary guidelines for medical applications.
• ASTM D3577 & D3578: Specifications for synthetic surgical and examination gloves widely used in healthcare.

Adherence to ISO 23464:2020 ensures nitrile cleanroom gloves meet critical standards for contaminant control, fostering reliability and quality assurance in high-precision manufacturing and research sectors. This standard is essential for manufacturers and users aiming to maintain stringent contamination limits and optimize cleanroom safety protocols.