ISO 19227:2018

Name: ISO 19227:2018 — Implants for surgery — Cleanliness of orthopedic implants — General requirements
SKU: ISO 19227:2018
Price: 30600 RUB
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Implants for surgery — Cleanliness of orthopedic implants — General requirements

Название (английский):

ISO 19227:2018

Implants for surgery — Cleanliness of orthopedic implants — General requirements

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 21 марта 2018 г.
Издание:: ISO IS 19227 edition 1 version 1
ICS:: 11.040.40

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Срок поставки:3 раб. дн. (перевод)

Цена:30 600 ₽

Описание (английский):

ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process. ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards. ISO 19227:2018 applies to in-process cleaning and final cleaning. ISO 19227:2018 does not apply to liquid or gaseous implants. ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 19227:2018 - "Implants for surgery - Cleanliness of orthopedic implants - General requirements" defines requirements and test methods for determining and controlling the cleanliness of orthopedic implants. The standard covers both in-process cleaning and final cleaning, and frames cleaning validation and controls within a risk management approach. It does not cover packaging or sterilization (these are addressed by other standards), nor does it apply to liquid/gaseous implants or cleaning performed by users.

Key topics and technical requirements

Scope and applicability: Applies to solid orthopedic implants and their manufacturing cleaning processes; excludes user-performed cleaning and packaging/sterilization requirements.

Risk management: Cleaning process design, validation and ongoing verification are driven by a documented risk assessment (linked to ISO 14971 principles).

Quality management: Activities must be performed within a formal quality management system (e.g., ISO 13485).

Cleaning process design: Defines the cleaning family concept, worst-case specimens, and critical in‑process cleaning steps to ensure consistent final cleanliness.

Validation and verification: Requires documented validation of cleaning processes and continued process verification during manufacturing.

Sampling and test specimens: Specifies sampling approaches and manufacturing of test dummies representative of production parts.

Test methods and acceptance criteria: Addresses methods for:

Visual inspection
Bioburden determination
Bacterial endotoxins
Organic contaminants (extraction and detection)
Inorganic contaminants
Particulate contamination
Cytotoxicity

Documentation: Requires records covering design, validation, sampling, test results and ongoing controls.

Applications and who uses it

ISO 19227:2018 is intended for:

Orthopedic implant manufacturers developing and validating cleaning processes.

Quality and regulatory affairs professionals responsible for device conformity and technical documentation.

Process engineers and production managers implementing in-process and final cleaning programs.

Contract manufacturers and cleaning service providers supplying cleaned implants or cleaning validation data.

Regulatory auditors and notified bodies assessing cleaning validation, residual contaminants and biological risk.

Practical uses include establishing cleaning acceptance criteria, designing worst-case test specimens, selecting extraction/detection methods for residues, and integrating cleaning validation with biological evaluation (ISO 10993‑1).

Related standards

ISO 10993-1 (biological evaluation of medical devices)

ISO 10993-5 (in vitro cytotoxicity)

ISO 11737-1 (microbiological methods; bioburden)

ISO 9377-2 and ASTM D7066 (methods for hydrocarbon/oil index and residues)

Keywords: ISO 19227:2018, cleanliness of orthopedic implants, cleaning validation, in‑process cleaning, final cleaning, risk management, implant manufacturers, medical device quality.

ISO 19227:2018

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

BS EN ISO 14971:2019+A11:2021

Medical devices. Application of risk management to medical devices.

BS EN ISO 13485:2016+A11:2021

Medical devices. Quality management systems. Requirements for regulatory purposes.

BS EN ISO 10993-14:2009

Biological evaluation of medical devices. Identification and quantification of degradation products from cera…

BS EN ISO 11737-1:2018

Sterilization of health care products. Microbiological methods - Determination of a population of microorgani…

BS EN ISO 9377-2:2000

Water quality. Determination of hydrocarbon oil index - Method using solvent extraction and gas chromatography