IS 13450 : Part 2 : Sec 12 : 2023/ISO 80601-2-12 : 2020Medical Electrical Equipment Part 2 Particular requirements for basic safety and essential performance Section 12 Critical care ventilators
(Superseding IS/ISO 80601-2-12 : 2011).
New Standard from Last Update.
NATIONAL FOREWORD
This Indian Standard (Part 2/Sec 12) which is identical with ISO 80601-2-12 : 2020 ‘Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Anaesthetic, Resuscitation and Allied Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.
This standard supersedes IS/ISO 80601-2-12 : 2011 ‘Medical electrical equipment: Part 2-12 Particular requirements for basic safety and essential performance critical care ventilators’ which superseded IS 11661 : 1986 ‘Specification for safety of lung ventilator for medical use’ to align with ISO 80601-2-12 : 2011. The ISO standard has been revised in 2020. This standard is a modified adoption of ISO 80601-2-12 : 2020, which is now brought under IS 13450 series in line with the adoption of other parts of ISO 80601 and IEC 60601 series.