ISO TS 16782-2016 PDF

Full title and description

St ISO TS 16782-2016 — Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller‑Hinton agar and broth for antimicrobial susceptibility testing. This Technical Specification defines the physical properties and performance acceptance criteria for dehydrated Mueller‑Hinton broth (dMHB) and dehydrated Mueller‑Hinton agar (dMHA) used as test media in antimicrobial susceptibility testing (AST).

Abstract

ISO/TS 16782:2016 provides standardized descriptions of the physical properties of dMHB and dMHA and specifies performance criteria and lot acceptance testing that manufacturers can apply to production lots so those lots are suitable for routine AST and for use by in vitro susceptibility testing device manufacturers. The document excludes supplements (for example blood or blood products) added to support fastidious organisms, and limits performance testing of dMHA to disc diffusion methods as described by CLSI and EUCAST.

General information

• Status: Published.
• Publication date: October 2016 (2016-10).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.20 — Clinical laboratory testing and in vitro diagnostic test systems.
• Edition / version: Edition 1 (2016).
• Number of pages: 21.

Scope

Specifies the physical property descriptions and performance criteria for dehydrated Mueller‑Hinton agar and dehydrated Mueller‑Hinton broth production lots to ensure consistent performance in antimicrobial susceptibility testing. The scope excludes supplements added after reconstitution (e.g., blood supplements for fastidious organisms). While dMHA can be used with MIC determination methods, this Technical Specification restricts its performance testing to disc diffusion methodologies (CLSI/EUCAST).

Key topics and requirements

• Definitions and physical property specifications for dehydrated Mueller‑Hinton agar (dMHA) and broth (dMHB).
• Performance criteria and acceptance testing procedures for production lots (lot-to-lot consistency and suitability for AST).
• Instructions on which additives/supplements are outside the Technical Specification (i.e., added after reconstitution).
• Specification that dMHA performance testing within this TS is limited to disc diffusion methodology and refers to established CLSI and EUCAST procedures.
• Quality control and documentation expectations for manufacturers to support consistent AST results.

Typical use and users

Intended for manufacturers of dehydrated culture media (Mueller‑Hinton agar and broth), quality assurance teams in media production, clinical microbiology laboratories, and manufacturers of in vitro antimicrobial susceptibility testing devices that rely on consistent media performance. It is used when establishing lot acceptance procedures, supplier qualification, and routine quality control to ensure reliable AST outcomes.

Related standards

Closely related ISO standards and technical documents include the ISO 20776 series (reference methods and evaluation of AST devices) and other AST guidance referenced by ISO/TS 16782; harmonized laboratory guidance from CLSI (for example M23 procedures for Mueller‑Hinton agar acceptability and disk diffusion QC) and EUCAST disc diffusion procedures are directly relevant.

Keywords

Mueller‑Hinton agar, Mueller‑Hinton broth, dMHA, dMHB, antimicrobial susceptibility testing, AST, lot acceptance, media quality, disc diffusion, CLSI, EUCAST, clinical laboratory testing.

FAQ

Q: What is this standard?

A: ISO/TS 16782:2016 is a Technical Specification that sets out physical descriptions and performance acceptance criteria for dehydrated Mueller‑Hinton agar and broth used in antimicrobial susceptibility testing.

Q: What does it cover?

A: It covers the properties and lot acceptance testing of dehydrated Mueller‑Hinton media so that production lots are suitable for AST; it excludes supplements added after reconstitution and limits performance testing of dMHA to disc diffusion methods (CLSI/EUCAST).

Q: Who typically uses it?

A: Media manufacturers, QA/QC personnel, clinical microbiology laboratories, and diagnostics manufacturers performing or validating AST devices and methods.

Q: Is it current or superseded?

A: The document was published in October 2016 (Edition 1) and was confirmed as current in ISO’s review cycle (confirmed in 2021). ISO’s lifecycle indicates the document is subject to periodic review and may be scheduled for revision. Users should check ISO updates or national standards bodies for any newer editions or revisions.

Q: Is it part of a series?

A: It sits within ISO’s clinical laboratory testing/AST collection and should be used in conjunction with related ISO standards (for example the ISO 20776 series on susceptibility testing reference methods and performance evaluation) and with CLSI/EUCAST procedural documents for disk diffusion and media acceptability.

Q: What are the key keywords?

A: Mueller‑Hinton, dehydrated medium, antimicrobial susceptibility testing, lot acceptance, quality control, disc diffusion, dMHA, dMHB, CLSI, EUCAST.