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YY 1277-2023: Steam sterilizer - Performance requirements for biosafety
YY 1277-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.080.10
CCS C 47
Replacing YY 1277-2016
Steam sterilizer - Performance requirements for biosafety
ISSUED ON: SEPTEMBER 5, 2023
IMPLEMENTED ON: SEPTEMBER 15, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 6
5 Test methods ... 8
Appendix A (Informative) Installation of the biological seal ... 12
Appendix B (Informative) Guide to the drainage safety test method ... 15
Appendix C (Informative) Guide to the exhaust safety test method ... 17
References ... 18
Steam sterilizer - Performance requirements for biosafety
1 Scope
This document specifies the biosafety performance requirements for pressure steam
sterilizers (hereinafter referred to as sterilizers) and describes the corresponding test
methods.
This document applies to the sterilization of materials, instruments, utensils, culture
media, waste and other items for the purpose of biosafety, so as to prevent the
contamination of personnel, animals, plants or the environment by pathogenic factors
transmitted by aerosols and other means.
The sterilizers specified in this document are generally used in laboratories or other
places with biosafety requirements and biosafety level II or above.
This document does not specify safety requirements related to the risk range of use, nor
does it specify requirements for validation and routine control of moist heat sterilization.
This document is not applicable to the sterilization of confined liquids.
2 Normative references
The provisions of the following documents constitute the essential clauses of this
document through normative references in this text. Among them, for referenced
documents with dates, only the versions corresponding to the dates are applicable to
this document; for referenced documents without dates, the latest versions (including
all amendments) are applicable to this document.
GB 18281.3 Sterilization of health care products - Biological indicators - Part 3:
Biological indicators for moist heat sterilization processes
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 biosafety
The hazards or potential risks caused by various biological factors to the country,
society, economy, people's health and ecological environment.
3.2 containment area
Areas with relatively high biological risks, where the airtightness of the enclosure
structure, airflow, personnel entry, and individual protection are controlled.
3.3 non-containment area
Areas with relatively low biological risks, which also refer to areas outside the
containment area.
4 Requirements
4.1 Double door interlock
Double-door sterilizers shall be equipped with double-door interlocking devices. In
normal use, the double doors cannot be unsealed at the same time. After the door on the
containment area side is unsealed, an effective sterilization cycle shall be carried out
before the door on the non-containment area side can be unsealed.
4.2 Instruments and display devices
4.2.1 For sterilizers used in laboratories or other places with a biosafety level of level 3
or 4, the sterilization chamber pressure gauge and pressure sensor shall be of diaphragm
type.
4.2.2 The display device on the non-containment area side of the double-door sterilizer
shall be able to display the cycle operation status.
4.3 Control system
The use authority of the control system shall be managed at level three or above.
4.4 Alarm
4.4.1 Abnormal alarm of exhaust gas filter
For sterilizers used in laboratories or other places with a biosafety level of level 3 or 4,
the manufacturer shall specify the range of pressure difference between the front and
rear ends of the exhaust gas filter; when the pressure difference between the front and
rear ends exceeds or falls below the set value, the sterilizer shall alarm.
4.4.2 Abnormal alarm of external utility facilities
4.4.2.1 The manufacturer shall specify the pressure range of the external steam source;
when the pressure of the external steam source exceeds the specified range, the sterilizer
shall alarm.
4.4.2.2 The manufacturer shall specify the external water source pressure range; when
the external water source pressure exceeds the specified range, the sterilizer shall alarm.
4.4.2.3 The manufacturer shall specify the external compressed air pressure range;
when the external compressed air pressure exceeds the specified range, the sterilizer
shall alarm.
4.5 Data transmission
Sterilizers used in laboratories or other places with a biosafety level of level 3 or 4 shall
have data transmission systems and data transmission interfaces. Data can be
transmitted through wired communication (such as Ethernet, fax, and audio and video
monitoring) or wireless communication.
4.6 Drainage safety
4.6.1 The sterilizer shall be equipped with a sampling interface for condensed water
discharged from the sterilization chamber.
4.6.2 The condensed water discharged from the sterilization chamber shall be sterile.
4.7 Exhaust safety
4.7.1 For sterilizers used in laboratories or other places with a biosafety level of level
2, it shall be determined whether the exhaust gas from the sterilization chamber uses a
sterilization device based on the risk assessment results. If necessary, the exhaust gas
from the sterilization chamber shall pass through at least a one-stage sterilization device,
and the exhaust gas from the sterilization chamber shall be sterile.
4.7.2 For sterilizers used in laboratories or other places with a biosafety level of level
3, the exhaust gas from the sterilization chamber shall pass through at least a one-stage
sterilization device, and the exhaust gas from the sterilization chamber shall be sterile.
4.7.3 For sterilizers used in laboratories or other places with a biosafety level of level
4, the exhaust gas from the sterilization chamber shall pass through at least a two-stage
sterilization device, and the exhaust gas from the sterilization chamber shall be sterile.
4.7.4 If a high-efficiency filter is used as a sterilization device for the exhaust gas, the
filter shall meet the following requirements:
a) The filtration efficiency of particles with a diameter of 0.2 μm shall not be less
than 99.99%;
b) Be able to withstand high-temperature steam not less than 140 ℃;
c) Use hydrophobic filter element;
5.2 Instrument and display device test
5.2.1 For sterilizers used in laboratories or other places with a biosafety level of level 3
or 4, refer to the quality certification documents of the pressure gauge and pressure
sensor provided by the manufacturer to determine whether the diaphragm type is used.
5.2.2 Run the sterilizer program and check whether the display device in the non-
containment area of the double-door sterilizer can display the cycle operation status.
5.3 Control system test
Check whether the use authority of the control system is managed at level three or above.
5.4 Alarm test
5.4.1 Abnormal alarm test of exhaust gas filter
Check whether the manufacturer has specified the range of pressure difference before
and after the exhaust gas filter. Connect a manually adjustable valve in series at the
pressure sensor in front of the exhaust gas filter; when the program runs to the state of
decreasing pre...