GB/T 19974-2018Sterilization of health care products -- General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces GB/T 19974-2005 "The characteristics of sterilization and sterilization factors for medical care products and the opening of medical device sterilization process

General requirements for hair, confirmation and general control. The main technical differences between this standard and GB/T 19974-2005 are as follows.

--- Added the definition of "Process Challenge Device (PCD)" (see 3.18).

This standard uses the translation method equivalent to ISO 14937.2009 "the characteristics of medical products sterilization and sterilization factors and medical devices

General requirements for the development, validation and routine control of bacterial processes.

The documents of our country that have a consistent correspondence with the international documents referenced in this standard are as follows.

Safety of electrical equipment for measurement, control and laboratory use - Part 4.

Special requirements for sterilizers and washer-disinfectors (idtIEC 61010-2-041.1995)

--- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management

(ISO 10993-1.2009, IDT)

--- GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances

(ISO 10993-17.2002, IDT)

--- GB 18282.1-2015 Health care products - Sterilization of chemical indicators - Part 1. General (ISO 11140-1.2005,

IDT)

---GB/T 19022-2003 Measurement management system measurement process and measurement equipment requirements (ISO 10012.2003, IDT)

--- GB/T 19973.1-2015 Microwaveological methods for the sterilization of medical devices - Part 1

Ding (ISO 11737-1.2006, IDT)

--- GB/T 19973.2-2018 Sterilization of medical devices - Microbiological methods - Part 2

Aseptic testing for validation and maintenance (ISO 11737-2.2009, IDT)

Introduction

A sterile medical device is a device that has no living microorganisms. The standard specifies the requirements for confirmation and routine control of the sterilization process.

When the device is to be provided in a sterile form, all undesired microbial contamination should be minimized prior to sterilization. Even medical devices

The product is produced under standard manufacturing conditions that meet the requirements of the quality management system (eg YY/T 0287-2003) and will still be carried before sterilization.

There are a small number of microorganisms, and such devices are non-sterile devices. The purpose of sterilization is to inactivate microorganisms and convert non-sterile instruments into sterile

instrument.

The kinetics of inactivation of pure microbial culture using physical factors and/or chemical factors for sterilization of medical devices can generally be carried out using residual microorganisms.

The exponential relationship between quantity and degree of sterilization is well described. This means that microbial survival is inevitable regardless of the degree of sterilization.

The probability. For established treatment methods, the survival probability of residual microorganisms depends on the number of microorganisms, resistance and microorganisms during treatment.

The environment in which it exists. Therefore, any product in the batch product that has undergone the sterilization process cannot be guaranteed to be sterile and batch processed through the sterilization process.

Sterility of a product is defined as the probability of the presence of living microorganisms in the medical device.

If satisfied, the requirements described in this standard will provide a moist heat that is expected to be used in medical devices with appropriate microbicidal activity.

Sterilization process. Moreover, compliance with this standard ensures that sterilization is reliable and repeatable, so that there is reason to believe that microbes survive after sterilization.

The probability is relatively low. The probability of microbial survival to achieve sterility requirements is dictated by the standard. (eg EN556-1 and ANSI/AAMI)

ST67).

General requirements for quality management systems such as design and development, production, installation and service are listed in ISO 9001, Medical Device Production Quality Management

See YY/T 0287 for special requirements. These quality management system standards believe that some processes in manufacturing cannot be fully validated.

Verification of the continued product inspection and testing, sterilization is such a process. Therefore, before the implementation of the sterilization process, it should be confirmed that the sterilization process

The effectiveness of the inspection should be routinely monitored and equipment should be maintained.

Exposure to a properly identified and accurately controlled sterilization process is not the only factor that ensures the product is sterile and suitable for the intended use.

Therefore, we should also pay attention to the following aspects.

a) the microbiological status of incoming raw materials and/or components;

b) any confirmation and routine control of the cleaning and disinfection procedures for the product;

c) control of the manufacturing, assembly and packaging environment of the product;

d) control of equipment and processes;

e) control of personnel and their health;

f) the packaging method and packaging materials of the product;

g) Storage conditions of the product.

The type of contamination of the sterilized product affects the effectiveness of the sterilization process. It is recommended to use the medical institution and follow the manufacturer's instructions.

The book requirements (see ISO 17664) are reproducible medical devices as special cases. Despite cleaning, these products may still be widely available

Contaminated by microorganisms and residual organic and/or inorganic pollution. Therefore, special attention should be paid to the cleaning and disinfection process during repeated processing of the device.

Confirmation and control.

The requirements that this standard claims to meet are the normative part of this standard. The guidelines in Appendix E are not intended to be normative requirements, nor are they

The reviewer's review form is provided. The interpretations and methods given in the guide should be considered as necessary means of meeting the requirements of the standard. If it can also be satisfied

The requirements of this standard, methods not specified in the guide can also be used.

The development, validation, and routine control of the sterilization process involves several inconsistent but related activities such as calibration, maintenance, product definition, and

Process definition, installation qualification, operational qualification, and performance qualification. Although the activities specified in this standard are grouped and arranged in a specific order, this is not

These activities are required to be in the order in which they are presented in this standard. The required activities do not need to be in order because the development and validation in the process can

Can be repeated. The responsibilities for activities that implement the requirements of this standard vary from case to case. The requirements of this standard stipulate the duties of all parties

Responsibility (see 4.2), but does not stipulate who the specific responsibilities belong to. Appendix E provides guidance on the assignment of responsibilities.

This standard has three distinct uses.

--- Manufacturers of medical devices that will sterilize their products without specific standards;

--- for manufacturers and users of health care institutions without specific standards;

--- As a framework for the development and revision of specific sterilization process standards.

Characteristics of sterilization and sterilization factors for healthcare products and

Development, validation and validation of medical device sterilization processes

General requirements for routine control

1 Scope

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.

Pieces. For undated references, the latest edition (including all amendments) applies to this document.

GB 18281.1-2015 Sterilization of biological indicators for health care products - Part 1. General (ISO 11138-1.2006, IDT)

YY/T 0287-2003 Medical device quality management system for regulatory requirements (ISO 13485.2003, IDT)

ISO 10012 Measurement Management System Measurement Methods and Measurement Equipment Requirements (Measurementmanagementsystems-

Requirementsformeasurementprocessesandmeasuringequipment)

ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalua-

tionofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess)

ISO 10993-17 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (Biological

evaluationofmedicaldevices-Part 17.Establishmentofalowablelimitsforleachablesubstances)

ISO 11140-1 Sterilization of health care products - Part 1 . General rules (Sterilization of health care)

products-Chemicalindicators-Part 1.Generalrequirements)

ISO 11737-1 Methods of sterilizing microbiology of medical devices - Part 1

(Sterilizationofmedicaldevices-Microbiologicalmethods-Part 1.Determinationofapopulationof

Microorganisms products)

ISO 11737-2 - Microbiological methods for the sterilization of medical devices - Part 2. Definitions, s

Sterility test (Sterilization of medical devices-Microbiological methods-Part 2. Testsofsterilityper-

Formedinthedefinition,validationandmaintenanceofasterilizationprocess)

Safety of electrical equipment for measurement, control and laboratory use - Part 4.

Special requirements for sterilizers and washer-disinfectors (Safetyrequirementsforelectricalequipmentformeasurement,con-

trolandlaboratoryuse-Part 2-040.Particularrequirementsforsterilizersandwasher-disinfectors

Usedtotreatmedicalmaterials)

3 Terms and definitions

The following terms and definitions apply to this document.

3.1

Bioburden

The total number of viable microorganisms on the surface or inside of the product and/or sterile barrier system.

[See GB/T 19971-2015, definition 2.2]

3.2

Biological indicator biologicalindicator

Specific resistance to the prescribed sterilization process, including a test system for live microorganisms.

[See GB/T 19971-2015, definition 2.3]

3.3

Change control changecontrol

Appropriate assessment and decision on the proposed changes to the product or program.

[See GB/T 19971-2015, definition 2.5]

3.4

Chemical indicator chemicalindicator

Abiotic indicator non-biologicalindicator

A test that exhibits one or more predetermined process variable changes based on chemical or physical changes that result from exposure to a sterilization process

system.

[See GB/T 19971-2015, definition 2.6]

3.5

Corrective action correctiveaction

Measures taken to eliminate the cause of the identified nonconformities or other undesired conditions.

Note 1. There may be several reasons for a failure.

Note 2. Corrective action is taken to prevent recurrence, and precautionary measures (3.17) are taken to prevent it from happening.

Note 3. Correction (3.6) and corrective action are different.

[See GB/T 19000-2008, Definition 3.6.5]

3.6

Correct corrective

Measures taken to eliminate identified nonconformities.

Note. Correction can be implemented in conjunction with corrective action (3.5).

[See GB/T 19000-2008, Definition 3.6.6]

3.7

Development

Develop a detailed activity.

[See GB/T 19971-2015, definition 2.13]

3.8

Establish establish

Determined by theoretical evaluation and confirmed by experiments.

[See GB/T 19971-2015, definition 2.17]

3.9

Fault fault

One or more process parameters are outside the specified tolerance range.

[See GB/T 19971-2015, definition 2.19]

3.10

Healthcare products healthcareproduct(s)

Medical devices (including in vitro diagnostic medical devices) or medical products (including biopharmaceutical products).

[See GB/T 19971-2015, definition 2.20]

3.11

Installation identification instalationqualification; IQ

Proof that the equipment has been provided and installed as required by the specification to obtain and form documented evidence.

[See GB/T 19971-2015, definition 2.22]

3.12

Material Safety Data Sheet materialsafetydatasheet; MSDS

A document detailing the material properties and their potential hazards to humans and the environment, and the necessary precautions for safe use and disposal of articles.

[See GB/T 19971-2015, definition 2.23]

3.13

Medical device medicaldevice

The intended use of the manufacturer is for one or more of the following specific purposes, for humans, whether used alone or in combination,

Equipment, appliances, equipment, utensils, implants, in vitro reagents or calibrators, software, materials or other similar or related items. These purposes are.

--- Diagnosis, prevention, monitoring, treatment or relief of the disease;

---Diagnosis, monitoring, treatment, mitigation or compensation of injuries;

--- research, substitution, regulation or support of anatomical or physiological processes;

---Support or sustain life;

---Pregnant control;

--- Disinfection of medical devices;

--- Provide medical information by inspecting samples taken from the human body in vitro.

The main design effects on the body surface or in the body are not obtained by pharmacological, immunological or metabolic means, but may have these

The means to participate and play a certain auxiliary role.

[See YY/T 0287-2003, definition 3.7]

Note. This definition in YY/T 0287-2003 was developed by the Global Coordination Working Group (GHTF2002).

3.14

Operational authentication operationalqualification; OQ

A process of obtaining and documenting evidence that an installed device is capable of operating within predetermined limits when used in accordance with operational procedures.

[See GB/T 19971-2015, definition 2.27]

3.15

Parameter release parametricrelease

The product is declared sterile according to records that demonstrate that the process parameters are within the specified tolerances.

[See GB/T 19971-2015, definition 2.29]

3.16

Performance qualification performancequalification; PQ

Prove that equipment that has been installed and operated in accordance with the operating procedures, can produce products that meet the specifications according to the predetermined specifications, obtain and form a document

The process of documenting evidence.

[See GB/T 19971-2015, definition 2.30]

3.17

Preventive action

Measures taken to eliminate the cause of potential nonconformities or other potentially undesirable conditions.

Note 1. There may be several reasons for a potential failure.

Note 2. Precautions are taken to prevent it from happening, and corrective actions are taken to prevent recurrence.

[See GB/T 19000-2008, Definition 3.6.4]

3.18

Process challenge device processchalengedevice; PCD

A device that constitutes a specific resistance to a sterilization process for evaluating the performance of the sterilization process.

[See GB/T 19971-2015, definition 2.33]

3.19

Process parameter processparameter

The specified value of the process variable.

Note. Sterilization process specifications include process parameters and their tolerances.

[See GB/T 19971-2015, definition 2.34]

3.20

Process variable processvariable

The conditions of the sterilization process, which can affect the killing of microorganisms.

Examples. time, temperature, pressure, concentration, humidity, wavelength.

[See GB/T 19971-2015, definition 2.35]

3.21

Recognized strain preservation library recognisedculturecolection

An international strain preservation institution established under the Budapest Convention on the Internationally Recognized Patent and Regulations for the Preservation of Microorganisms.

[See GB/T 19971-2015, definition 2.38]

3.22

Reference microbial referencemicroorganism

A strain obtained from a recognized strain storage library.

[See GB/T 19971-2015, definition 2.39]

3.23

Requalification

A part of the validation activity that was re-executed to confirm that a prescribed process continued to be qualified.

[See GB/T 19971-2015, definition 2.40]

3.24

Supply service

Various external sources of supply necessary for the operation of the equipment.

Examples. electricity, water, compressed air, drainage systems.

[See GB/T 19971-2015, definition 2.41]

3.25

Specification

Explain in detail in the approved documents.

[See GB/T 19971-2015, definition 2.42]

3.26

Sterile sterile

No living microorganisms.

[See GB/T 19971-2015, definition 2.43]

3.27

Sterile sterility

No microbial survival status.

Note. This absolute statement that there is no microbial presence cannot be confirmed in practice [see the description of the term "sterilization" (3.28)].

[See GB/T 19971-2015, definition 2.45]

3.28

Sterilization sterilization

A confirmed process for making the product free of viable microorganisms.

[See GB/T 19971-2015, definition 2.47]

Note. During sterilization, the inactivation characteristics of microorganisms are expressed as an exponential function. Therefore, the presence of living microorganisms on any single piece of product can be expressed in terms of probability. General

The rate can be reduced to very low, but it is impossible to drop to zero. (See "Aseptic Assurance Level" in GB/T 19971)

3.29

Sterilization load sterilizationload

Use a given sterilization process with the items to be sterilized or sterilized.

[See GB/T 19971-2015, definition 2.48]

3.30

Sterilization process sterilizationprocess

A series of actions and operations required to achieve aseptic requirements.

Note. This series of operations includes product pretreatment (if required), exposure to the appropriate sterilization factors under the specified conditions, and required post-treatment. The sterilization process does not

Includes processes such as cleaning, disinfection, or packaging prior to sterilization.

[See GB/T 19971-2015, definition 2.49]

3.31

Sterilization factor sterilizationagent

Under the specified conditions, it has sufficient vitality to achieve sterile physical or chemical substances, or a combination thereof.

[See GB/T 19971-2015, definition 2.50]

3.32

Survivor curve survivorcurve

A graph showing the inactivation of the total number of microorganisms as a function of increasing exposure to inactivation factors under specified conditions.

[See GB/T 19971-2015, definition 2.51]

3.33

Aseptic test testforsterility

After the product has been sterilized, the product is technically operated according to the Pharmacopoeia.

3.34

Sterility test testofsterility

Technical operation to determine the presence or absence of living microorganisms on a unit product or part thereof, is a development, confirmation or re-identification

section.

[See GB/T 19971-2015, definition 2.54]

3.35

Confirmation of validation

A documented procedure for determining the acquisition, recording, and interpretation of the results required for a product that meets the predetermined specifications for a process.

[See GB/T 19971-2015, definition 2.55]

4 Quality management system elements