ANSI AAMI ISO 11138-3-2017

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ANSI/AAMI/

ISO 11138-3:

2017

Sterilization of health care

products—Biological

indicators—Part 3: Biological

indicators for moist heat

sterilization processes

American

National

Standard

Objectives and uses of AAMI standards and

recommended practices

It is most important that the objectives and potential uses of an

AAMI product standard or recommended practice are clearly

understood. The objectives of AAMI's technical development

program derive from AAMI's overall mission: the advancement of

medical instrumentation. Essential to such advancement are (1) a

continued increase in the safe and effective application of current

technologies to patient care, and (2) the encouragement of new

technologies. It is AAMI's view that standards and recommended

practices can contribute significantly to the advancement of

medical instrumentation, provided that they are drafted with

attention to these objectives and provided that arbitrary and

restrictive uses are avoided.

A voluntary standard for a medical device recommends to the

manufacturer the information that should be provided with or on

the product, basic safety and performance criteria that should be

considered in qualifying the device for clinical use, and the

measurement techniques that can be used to determine whether the

device conforms with the safety and performance criteria and/or to

compare the performance characteristics of different products.

Some standards emphasize the information that should be provided

with the device, including performance characteristics, instructions

for use, warnings and precautions, and other data considered

important in ensuring the safe and effective use of the device in the

clinical environment. Recommending the disclosure of

performance characteristics often necessitates the development of

specialized test methods to facilitate uniformity in reporting;

reaching consensus on these tests can represent a considerable part

of committee work. When a drafting committee determines that

clinical concerns warrant the establishment of minimum safety and

performance criteria, referee tests must be provided and the reasons

for establishing the criteria must be documented in the rationale.

A recommended practice provides guidelines for the use, care,

and/or processing of a medical device or system. A recommended

practice does not address device performance per se, but rather

procedures and practices that will help ensure that a device is used

safely and effectively and that its performance will be maintained.

Although a device standard is primarily directed to the

manufacturer, it may also be of value to the potential purchaser or

user of the device as a frame of reference for device evaluation.

Similarly, even though a recommended practice is usually oriented

towards healthcare professionals, it may be useful to the

manufacturer in better understanding the environment in which a

medical device will be used. Also, some recommended practices,

while not addressing device performance criteria, provide

guidelines to industrial personnel on such subjects as sterilization

processing, methods of collecting data to establish safety and

efficacy, human engineering, and other processing or evaluation

techniques; such guidelines may be useful to health care

professionals in understanding industrial practices.

In determining whether an AAMI standard or recommended

practice is relevant to the specific needs of a potential user of the

document, several important concepts must be recognized:

All AAMI standards and recommended practices are voluntary

(unless, of course, they are adopted by government regulatory or

procurement authorities). The application of a standard or

recommended practice is solely within the discretion and

professional judgment of the user of the document.

Each AAMI standard or recommended practice reflects the

collective expertise of a committee of health care professionals and

industrial representatives, whose work has been reviewed

nationally (and sometimes internationally). As such, the consensus

recommendations embodied in a standard or recommended practice

are intended to respond to clinical needs and, ultimately, to help

ensure patient safety. A standard or recommended practice is

limited, however, in the sense that it responds generally to

perceived risks and conditions that may not always be relevant to

specific situations. A standard or recommended practice is an

important reference in responsible decision-making, but it should

never replace responsible decision-making.

Despite periodic review and revision (at least once every five

years), a standard or recommended practice is necessarily a static

document applied to a dynamic technology. Therefore, a standards

user must carefully review the reasons why the document was

initially developed and the specific rationale for each of its

provisions. This review will reveal whether the document remains

relevant to the specific needs of the user.

Particular care should be taken in applying a product standard

to existing devices and equipment, and in applying a recommended

practice to current procedures and practices. While observed or

potential risks with existing equipment typically form the basis for

the safety and performance criteria defined in a standard,

professional judgment must be used in applying these criteria to

existing equipment. No single source of information will serve to

identify a particular product as "unsafe". A voluntary standard can

be used as one resource, but the ultimate decision as to product

safety and efficacy must take into account the specifics of its

utilization and, of course, cost-benefit considerations. Similarly, a

recommended practice should be analyzed in the context of the

specific needs and resources of the individual institution or firm.

Again, the rationale accompanying each AAMI standard and

recommended practice is an excellent guide to the reasoning and

data underlying its provision.

In summary, a standard or recommended practice is truly

useful only when it is used in conjunction with other sources of

information and policy guidance and in the context of professional

experience and judgment.

INTERPRETATIONS OF AAMI STANDARDS

AND RECOMMENDED PRACTICES

Requests for interpretations of AAMI standards and recommended

practices must be made in writing, to the AAMI Vice President,

Standards Policy and Programs. An official interpretation must be

approved by letter ballot of the originating committee and

subsequently reviewed and approved by the AAMI Standards

Board. The interpretation will become official and representation of

the Association only upon exhaustion of any appeals and upon

publication of notice of interpretation in the "Standards Monitor"

section of the AAMI News. The Association for the Advancement

of Medical Instrumentation disclaims responsibility for any

characterization or explanation of a standard or recommended

practice which has not been developed and communicated in

accordance with this procedure and which is not published, by

appropriate notice, as an official interpretation in the AAMI News.

American National Standard ANSI/AAMI/ISO 11138-3:2017

(Revision of ANSI/AAMI/ISO 11138-3:2006/(R)2015

Sterilization of health care products—Biological

indicators—Part 3: Biological indicators for moist heat

sterilization processes

Approved 14 April 2017 by

AAMI

Approved 1 August 2017 by

American National Standards Institute

Abstract: Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators

and test methods intended for use in assessing the performance of sterilization processes

employing moist heat as the sterilizing agent.

Keywords: carrier, organism, resistance, packaging, value

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标签： #ISO

摘要：

ANSI AAMI ISO 11138-3-2017 是一项关于医疗保健产品灭菌过程中使用的生物指示剂的专业国际标准，具体针对含环氧乙烷的灭菌工艺。该标准由美国国家标准协会（ANSI）、医疗器械促进协会（AAMI）与国际标准化组织（ISO）联合发布，规定了用于验证和监控环氧乙烷灭菌效果的生物指示剂的性能要求、测试方法、标签信息及运输储存条件。遵循此标准可确保灭菌过程的有效性和可重复性，帮助医疗机构和制造商降低感染风险、提高质量控制水平，并符合全球监管合规要求。无论是从事灭菌验证的工程师、质量管理

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ANSI AAMI ISO 11138-3-2017

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