New Standard from Last Update.

1. SCOPE

This Indian Standard specifies requirements for operator powered resuscitators where ventilation pressure is generated mechanically by the operator through compression of a pedal using their foot (hereafter referred to as pedal operated resuscitators) and which are portable and intended to provide when breathing is inadequate. Pedal operated resuscitators for infants and children are designated according to body mass range and approximate age equivalent. Electrically and gas-powered resuscitators are not covered by this Standard.

2. REFERENCES

The standards listed below contain provisions which, through reference in this text, constitute provision of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreement based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated:

IS/ISO 5356-1 : 2015 Anaesthetic and respiratory equipment - Conical connectors: Part 1 Cones and sockets (first revision)

IS/ISO 9170-1 : 2008 Terminal units for medical gas pipeline systems: Part 1 Terminal units for use with compressed medical gases and vacuum

IS/ISO 10651-4 : 2002 Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 4 Particular requirements for operator-powered resuscitators

IS/ISO 11607-1 : 2019 Packaging for terminally sterilized medical devices: Part 1 Requirements for materials, sterile barrier systems and packaging systems (first revision)

IS/ISO 15223-1 : 2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied: Part 1 General requirements (second revision)