51
3M
™
Steri-Vac
™
Sterilizer/Aerator GS Series
Site Planning and Installation Guide
70-2011-5643-0 Issue Date: 10/2015
ANNEX E
Bibliography and Compliance References
Equipment and Ethylene Oxide (EO) Compliance Documents
Biological evaluation of medical devices – Part 7:
Ethylene oxide sterilization residues
AAMI/ISO 10993-7
Sterilization of health care products – Ethylene
oxide – Part 1: Requirements for development,
validation, and routine control of a sterilization
process for medical devices.
AAMI/ISO 11135-1
Automatic, general purpose ethylene oxide
Sterilizer/Aerators and ethylene oxide sterilant
sources intended for use in health care facilities
ANSI/AAMI ST24
Ethylene oxide sterilization in health care
facilities: Safety and effectiveness
ANSI/AAMI ST41
Application of risk management for IT Networks
incorporating medical devices – Part 1: Roles,
responsibilities and activities
ANSI/AAMI/IEC
80001-1:2010
ANSI/AAMI/ISO
62304
Medical device software – Software life cycle
processes
AOAC Official Method of Analysis of Official
Analytical Chemist (AOAC), 14th Ed., Chapter 4,
Disinfectants, Par. 4.033-4.035.
AOAC
ASHRAE
American Society of Heating, Refrigerating, and
Air-Conditioning Engineers. Ventilation of health
care facilities. ANSI/ASHRAE Standard 170.
Atlanta: ASHRAE, 2008.
American Society of Heating, Refrigerating, and
Air-Conditioning Engineers. HVAC Design Manual
for Hospitals and Clinics; 2nd ed. Atlanta, GA.
ASHRAE; 201.4
ASHRAE; 201.4
Limits and methods of measurement of
electronic disturbance characteristics of
industrial scientific and medical (ISM)
radiofrequency equipment.
Australian Standard
for EMC –
AS/NZS 2064
EMC Directive
2004/104/EC
Electromagnetic Compatibility
Sterilizer/Aerators for Medical Purposes – Ethylene
Oxide Sterilizer/Aerators – Requirements and Test
Methods
EN 1422
Medical Devices – Application of usability
engineering to medical devices
EN 62366
National Emission Standards for Hazardous
Air Pollutants for Source Categories – National
Emission Standards for Hospital Ethylene Oxide
Sterilizer/Aerators
EPA 40 CFR Part 63;
Subpart WWWWW
FCC part 15
Electromagnetic Compatibility
Safety requirements for electrical equipment for
measurement, control, and laboratory use – Part
1: General Requirements
IEC/EN 61010-1
Safety requirements for electrical equipment for
measurement, control and laboratory use – Part
2-010: Particular requirements for laboratory
equipment for the heating of materials
IEC/EN 61010-2-010
Safety requirements for electrical equipment for
measurement, control and laboratory use – Part
2-040: Particular requirements for Sterilizer/
Aerators and washer-disinfectors used to treat
medical materials.
IEC/EN 61010-2-040
Biological evaluation of medical devices – Part
17: Establishment of allowable limits for leachable
substances
ISO 10993-17
“Sterilant Use of EO in Hospitals & Health
Care Facilities,” ANNEX A, Table VII; OSHA EO
Standard: 29 CFR 1910 Occupational Exposure
to Ethylene Oxide.
OSHA 29 CFR 1910
OSHA 29 CFR
1910.1047
General Industry Standard Subpart Z (Toxic and
Hazardous Substances; Ethylene Oxide)
ANNEX F
Disposal of Packaging
Recycle packaging materials according to facility policy. Dispose of non-recycled packaging materials into general waste or according to facility policy.
