Device specific ISO standards
IEC 60601-1:2005+AMD1:2012 CSV (consolidated version) This standard specifies requirements for electromedical devices; it has more than 60 related publications, that describe very specific areas of electromedical devices., since the device uses an active source of energy.
The IEC 60601-1 shows the general requirements for eletrical security for medical device with active parts.
The tests are Type Tests (according to subclause 5.1), that use a representative sample for the tests (see subclause 5.2), with normal use conditions (20 - 30 °C) (according to subclause 5.3 and subclause 5.7). Then the device is to be tested under the least favourable working conditions (according to subclause 5.4).
Relatively to the currents limits we have (according to subclauses 8.7.1, 8.7.2, 8.7.3):
- To test leakege currents and patient auxiliary currents verify the allowable value (see the table 1), The values of a.c. apply to currents having a frequency not less than 0,1 Hz.
- The allowable values of the touch current are 100 μA in normal condition and 500 μA in single fault condition.
- The allowable values of the earth leakage current are 5 mA in normal condition and 10 mA in single fault condition.
EN 62304:2006+A1:2015 This standard specifies how to design and code software for medical devices and sets requirements for SW change control.
BS EN 80001-1:2011 and PD IEC/TR 80001-2-1:2012
EN ISO 11607-1:2009+A1:2014 This standard specifies how the devices shall be packaged to allow sterilization and ensure that they remain sterile. You may also be interested in ISO 14644-1 This standard specifies requirements for the manufacturing environments.
NOTE: this standards has multiple chapters that may not be required while designing a medical device but will be mandatory during industrialization
EN ISO 11135:2014 You may also be interested in EN ISO 11138-2:2017
ISO 10993-1 and any of the additional chapters of this standard that may be applicable to your specific device- The device comes into contact with the body. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices. It is compiled from numerous International and National Standards and Guidelines concerning the biological evaluation of medical devices. It is intended to be a guidance document for the biological evaluation of medical devices within a risk management process, as part of the overall evaluation and development of each device. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, thus enabling a full evaluation to be made of the biological responses to each medical device, relevant to its safety in use. It must be appreciated that the term “medical device” is wide-ranging and, at one extreme, consists of a single material, which may exist in more than one physical form, and at the other extreme, of a complex instrument or piece of apparatus, consisting of numerous components made of more than one material.The parts of ISO 10993-1 applicable in this device are as follows.
- — Part 1: Evaluation and testing within a risk management process
- — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- — Part 7: Ethylene oxide sterilization residuals
- — Part 9: Framework for identification and quantification of potential degradation products
- — Part 10: Tests for irritation and skin sensitization
- — Part 13: Identification and quantification of degradation products from polymeric medical devices
- — Part 18: Chemical characterization of materials
- — Part 19: Physico-chemical, morphological and topographical characterization of materials (Technical Specification)
- — Part 20: Principles and methods for immunotoxicology testing of medical devices (Technical Specification)
General Standards
EN ISO 13485:2016 This standard specifies requirements for all entities involved in medical devices, in all stages of the product life cycle: from design to manufacture to installation to disposal.
EN ISO 14971:2012 This standard specifies requirements for designers and manufacturers of medical devices, in order to minimize the risk of the device itself. There is no “risk zero” device but many activities can be implemented to reduce and manage risk. This standard provides useful checklists and also guidance on the most widespread risk management techniques such as FMEA
IEC 62366-1 This standard provides guidance on how to manage the human factors while designing a medical device (usability engineering). NOTE: chapter -2 of ths same standards will provide comments and integrations
EN ISO 15223-1:2016 This standard lists a series of symbols that may be applicable in labels of medical devices