Changes in regulation (Jan - Oct 2021)

1. Harmonized with ISO 6009:2006

2. The range of needle sizes was expanded to 0.18 mm

3. The color coding for new sizes was expanded

1. Harmonized with IEC 60601-2-34:2011

2. The standard applies to the requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

3. The standard does not apply to catheter tubing, catheter needles, Luer locks, taps and taps tables connected, and non-invasive blood pressure monitoring equipment

1. Harmonized with IEC 60601-2-3:2016

2. The standard applies to requirements for the safety of short-wave therapy equipment

3. Some clauses of the standard do not apply to low power equipment

1. Harmonized with IEC 60601-2-23:2011

2. The standard applies to skin monitors used in the treatment of adults, children and newborns, including the operation of these devices during fetal monitoring at birth

3. The standard does not apply to hemoglobin saturation oximeters and devices installed on the surface of the body outside the skin (for example, connective tissue and mucous membranes).

1. The standard was expanded

Previous version: This standard considers measures to ensure the safety of the patient and the operator in the operation of medical electrical equipment

Current version: This standard outlines the basic aspects, which should be considered when developing standards to ensure the safety of medical electrical equipment.

1. The standard applies to magnetic resonance imaging equipment (MR equipment) to ensure the required accuracy of the data obtained in order to increase the diagnostic value of the results of MR studies.

2. It establishes methods for testing the quality parameters of structural and quantitative images of MR equipment. Test methods are not designed to assess mechanical or electrical performance

1. The standard specifies general requirements for the procedure for assessing the impact of factors of the magnetic resonance (MR) environment on an implantable medical device (IMD) in order to determine the safety of conducting an MR study in patients in whom the device is installed

2. The standard is not designed to address safety issues associated with the use of IMD and not related to the presence of an MR environment, if any.

1. Devices for in vitro diagnostics and medical systems have been added to the scope.

2. The standard no longer applies to:

– disposable non-electrical medical devices;

– eyeglass optics (glasses for optical vision correction, eyeglass frames, spectacle and contact lenses) and intraocular lens;

– personal protective equipment for eyes and face, respiratory organs, hands, feet and other parts of the body that are subject to the occupational safety standards system;

– consumables;

– reagents for in vitro diagnostics;

– software as an individual medical device.

1. Harmonized with ISO/TR 10993-22:2017

2. The standard applies to medical devices containing or consisting of nanomaterials. It specifies the requirements for assessing their biological action

3. The standard does not specify requirements for the test protocol of nanomaterials.

1. Harmonized with ISO 10993-4:2017

2. The standard applies to medical devices (MD), including materials intended for the manufacture of MD which interact with blood, and establishes general requirements for the assessment of their biological action

1. The standard applies to medical and endotherapy devices and establishes general technical requirements and test methods.

2. The standard does not apply to endomicroscopes, as well as to endoscopic complexes and endotherapeutic devices containing electrical circuits and used in endoscopic examination, and video endoscopes.

1. The scope has not changed

2. In the new version, the requirements and values of the prosthesis surface roughness were slightly adjusted

3. In the new version, the requirements for the processing of polymer tibial and patellar components were added

1. Harmonized with ISO 14242-1:2014

2. The scope has not changed

3. In the new version, the requirements for reagents and materials for testing were expanded

1. Harmonized with ISO 14242-2:2016

2. This standard specifies methods for the assessment of the wear and tear of the acetabular component of total hip-joint prostheses using gravimetric techniques and changes in the dimensional form of components tested in accordance with ISO 14242‑1 or ISO 14242‑3. (ISO 14242-3 was added)

1. This standard establishes the basic requirements, which should be contained in the description of the subject matter of the procurement: the technical requirement for public procurements, for the preparation of technical specifications in the public procurement of medical devices such as vascular stents.

2. The standard does not apply to biodegradable stents.

GOST R ISO 21535-2020

1. The scope has not changed

2. Errors and typos have been eliminated

3. Several requirements for inactive surgical implants have been added/adjusted

1. Harmonized with ISO 5832-2:2018

2. The standard was upgraded after test methods had been updated (new versions were released)

1. Harmonized with ISO 5832-3:2016

2. The standard was upgraded after test methods had been updated (new versions were released)

1. The standard classifies dental plaster materials depending on their purpose. It establishes the technical requirements and test methods for dental plaster materials. It establishes the requirements for labelling, packaging and instructions for use.

2. The standard does not apply to dental bone grafts consisting of calcium sulfate hemihydrate (or plaster)

1. This standard applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling, or to automate any other aspect of a medical device quality system as described in ISO 13485.

2. This standard does not apply to:

– software used as a component, part or accessory of a medical device;

– software that is itself a medical device.

1. Harmonized with ISO 15223-1:2016

2. The scope and the symbols have not changed

3. The requirements and symbol notes have been adjusted

1. The scope has not changed

2. The prosthetic socket materials which come into contact with the user's body no longer have to meet the biological safety requirements of GOST ISO 10993-5

3. The standard applies to the individually customized external upper-limb prostheses belonging to class 06 18 according to GOST R ISO 9999 and intended for users with amputation and/or birth defects of the upper limbs. The standard does not apply to work prostheses and self-service devices.

1. The description of the scope has been expanded

This standard applies to tutors on the person’s upper and lower limbs which are the technical means of rehabilitation and which are used in the rehabilitation process of patients and disabled people with spinal cord injuries.

1. The scope has changed

The standard applies to prosthetic and orthopedic products (hereinafter referred to as products) designed to restore the appearance and basic functions of the lost upper limb: cosmetic and functional and cosmetic prostheses of the upper limb and products for correcting, fixing and reducing the load on the affected segment(s) of the upper limb joint(s) — orthopedic devices for the upper limb used as one of the components in the comprehensive rehabilitation process.

The standard does not apply to upper limb prostheses active with an external energy source, mechanical and combined prostheses, endoprostheses. Requirements for tutors for upper limbs are according to GOST R 52878, and for spinal assistants and headholders according to GOST R 57892.  Requirements for prosthetic and orthopedic devices for the lower limbs are according to GOST R 53869 and GOST R 52878.

1. The standard applies to spinal assistants-posture correctors (hereinafter referred to as the products) for children and adults which were designed for raising the upper shoulder girdle, reclining and partially reducing the load on the upper thoracic and middle thoracic spine in an orthopedically corrected position during treatment and for the prevention of diseases and deformities

2. Technical requirements and test methods

1. The standard applies to spinal assistants-posture correctors (hereinafter referred to as the products) for children and adults which were designed for raising the upper shoulder girdle, reclining and partially reducing the load on the upper thoracic and middle thoracic spine in an orthopedically corrected position during treatment and for the prevention of diseases and deformities

2. Classification, technical requirements and control methods

1. The scope has changed:

The standard applies to manual wheelchairs designed for the movement of users with a body weight not exceeding 125 kg, indoors and outdoors, propeled and driven by the user independently or by an accompanying person (hereinafter referred to as the wheelchairs), which belong to the following classification groups 12 22 03; 12 22 06, 12 22 09 and 12 22 18 according to GOST R ISO 9999, as well as to the types 7-01-01, 7-01-03, 7-02-01, 7-02-03 and 7-02-04 according to [1], [2] and GOST R 58266.

This standard does not apply to:

– a manual wheelchair with an additional power base;

– wheelchairs moved with the use of the feet;

– wheelchairs with an auxiliary power (not manual) drive, as well as active wheelchairs (for disabled people and disabled children);

– small-sized manual wheelchairs (mobile platforms for disabled people);

– electrically powered wheelchairs;

– customized wheelchairs;

– wheelchairs with additional support for the user's head and body, including for patients with infantile cerebral palsy.