ISO Standards for Hospitals

Written by ben taylor
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ISO Standards for Hospitals
Hospitals worldwide adhere to ISO-established safety parameters. (health centre sign. access to health centre image by L. Shat from

The International Organization for Standardization (ISO) has several schedules that hospitals follow in order to maintain their ISO certification. The standards cover surgical gloves, medical gloves and even the wheels used on hospital beds. All ISO standards for hospitals are updated regularly and outline the pinnacle of hospital performance and safety standards for the benefit of patients, families and health care professionals alike.

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Surgical Gloves

ISO 10282: 2002 details packaging and storage requirements for surgical gloves. The goal of the standard is to prevent cross-contamination between patients, health care professionals and gloves. ISO intends this standard to be a performance and safety guide concerning rubber gloves. The standard applies to single-use gloves, but does not apply to examination or procedure gloves.

ISO Standards for Hospitals
Surgical gloves should meet an ISO quality standard. (surgical team during operation: working on open wo image by alma_sacra from

Non-Sterile Gloves

ISO 11193: 2008 pertains to hospital gloves that a health care professional would use in handling contaminated medical materials. ISO 11193:2008 has two sections and concerns the bulk storage and packaging requirements for non-surgical gloves; it does not cover the safe and proper usage of examination gloves.

Part one concerns packaging and bulk storage while part two concerns gloves intended for use in diagnostic or therapeutic procedures with the goal of protecting patients from cross-contamination.

Non-surgical gloves must meet ISO standards as well.
Non-surgical gloves must meet ISO standards as well. (medical gloves image by sasha from

Powdered Rubber Medical Gloves

ISO 21171:2006 describes standards for the presence of removable powder on the surface of medical gloves. There are three methods: Method A pertains to powdered gloves and Methods B and C for powder-free gloves. The standard does not address safety issues that may be associated with powdered gloves, nor does it prescribe limits on the amounts that may be present.

ISO Standards for Hospitals
Some hospital gloves use skin powder to reduce hand irritation. (skin care image by Allyson Ricketts from

Medical Face-Mask Quality

ISO 22609:2004 addresses a laboratory testing method which measures how effectively medical face masks resist penetration by a splash of synthetic blood. The standard primarily concerns the performance of materials from which the masks are manufactured and does not address the mask's design, construction, interfaces or other factors which may affect the overall protection.

ISO 22609 does not cover a mask's resistance to airborne pathogens.
ISO 22609 does not cover a mask's resistance to airborne pathogens. (medical mask image by Gina Smith from

Castors and Wheels on Hospital Beds

ISO 22882: 2004 specifies technical requirements and dimensions for wheels and locking mechanisms on hospital beds. The standard addresses swivel-type castors and wheels that have a dimension of 100mm or more. Nine countries adhere to this standard, most of them in Europe; an additional 12 countries acknowledge the standard's validity.

A total of 21 countries observe ISO specifications relating to hospital beds.
A total of 21 countries observe ISO specifications relating to hospital beds. (empty exam room image by Pix by Marti from

Hospital Bed Performance

ISO 60601:2009 addresses the basic function, performance and safety features of many hospital beds. The standard comes in two sections, the first of which replaced an earlier standard. ISO 60601 applies only to beds that are intended for adults and focuses on modernising existing safety benchmarks. The first section of ISO 60601 was updated in 2010 and covers electrical equipment associated with hospital beds; the second section was updated in 2009 and covers the safety of the bed apparatus itself.

Heating Pads and Blankets

ISO 80601: 2009 covers safety concerns related to heating pads, blankets and other electrical bedding used on pedeatric patients. The standard establishes safety parameters which minimise health risks to patients and health care professionals, as well as specific tests for the devices. ISO 80601: 2009 updates the 1996 version of the same standard.

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