ISO/TR 17327-2:2021

Name: ISO/TR 17327-2:2021 — Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings
SKU: ISO/TR 17327-2:2021
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Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings

Название (английский):

ISO/TR 17327-2:2021

Non-active surgical implants — Implant coating — Part 2: Reference standards related to coatings

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 12 апреля 2021 г.
Издание:: ISO TR 17327 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

This document provides lists of reference standards which contain general information, implant device or application-specific information, material specifications, or test methods related to coatings. These reference standards can be used to develop product coatings for specified applications when using ISO 17327-1 to address general coating requirements. This document is applicable to coatings on non-active surgical implants.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TR 17327-2:2021 is a technical report from ISO addressing implant coatings for non‑active surgical implants. It does not set new performance limits; instead it provides curated lists of reference standards (international and national) that contain general guidance, device- or application‑specific information, material specifications, and test methods related to implant coatings. The document is intended to be used with ISO 17327-1, which defines the generic coating properties and characterization needs.

Key topics and requirements

Scope and purpose

Applicable to coatings on non‑active surgical implants.
Helps link ISO 17327-1’s generic coating requirements to existing, relevant standards.

Reference mapping

Reference standards are grouped by: general standards, implant-related standards (cardiovascular, orthopaedic, other), and compositional specification / test method standards.
Each referenced standard is mapped to ten coating properties introduced in ISO 17327-1:
- Chemical composition
- Phase composition
- Surface texture
- Coating integrity
- Dissolvability
- Coating thickness
- Adhesion strength
- Abrasion resistance
- Porosity and pore size
- Surface wettability

Designation of relationships

Entries indicate whether a reference provides a Test Method (TM), a Requirement (R), or General Information (GI) for a given property - so users can identify applicable test standards (e.g., ASTM, ISO, JIS, USP) and regulatory guidance (e.g., FDA).

Practical guidance

Tables (e.g., for cardiovascular and orthopaedic implants) point to specific standards such as ISO 5840 (cardiovascular), ISO 13779 (hydroxyapatite/orthopaedic), ISO 10993-18, ASTM methods, and compositional tests (e.g., ISO 9277).

Applications - who uses it and why

Medical device manufacturers designing or qualifying coatings for non‑active implants (orthopaedic, cardiovascular, dental, other).

R&D and materials engineers selecting coating materials and planning characterization matrices.

Quality and regulatory affairs teams mapping device testing to recognized standards for submissions and conformity assessments.

Testing laboratories / contract manufacturers identifying accepted test methods for properties such as adhesion, thickness, porosity, or dissolution.

Notified bodies and auditors using the referenced standards to assess compliance with coating characterization expectations.

Related standards and practical notes

Use ISO/TR 17327-2 together with ISO 17327-1 to define characterization scope, then consult the referenced standards (ISO, ASTM, JIS, USP, FDA guidance) for specific test methods and limits.

The report is a starting point - referenced standards themselves must be reviewed for full technical details and applicability to a specific coating/substrate/device combination.

Keywords: ISO TR 17327-2:2021, implant coating, non-active surgical implants, coating characterization, ISO 17327-1, reference standards, test methods, adhesion strength, coating thickness, porosity.

ISO/TR 17327-2:2021

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications - who uses it and why

Related standards and practical notes

Технические детали

BS ISO 17327-1:2018

Non-active surgical implants. Implant coating. General requirements.

ISO 5840-2:2021

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

ISO 13779-2:2018

Implants for surgery — Hydroxyapatite — Part 2: Thermally sprayed coatings of hydroxyapatite

ISO 10993-18:2020

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials wit…

ISO 9277:2010

Determination of the specific surface area of solids by gas adsorption — BET method