The following provides additional requirements for developing hardware and software systems for medical devices per 60601-1 guidelines which are over and above MicroTools’ standard operating procedures and processes.

Additional Proposal Phase Requirements

MicroTools shall:

• identify if the project will create a Programmable Electrical Medical System (PEMS[1]) per 60601-1 during the proposal phase.
• identify within each PEMS, the Programmable Electronic Subsystem (PESS[2]) per 60601-1.
• provide a unique identifier for each separately build-able software configuration item[3] and the identifier shall be accessible through some means. This identifier shall include the unique version of the software. Note: the software identifier need not be on the outside of the unit. Additional separately build-able software configuration items can be added to the project after the proposal stage, but this would constitute a failure to identify the scope of the project during the proposal phase.
• In addition, 60601-1 requires 14971 Risk Management Process[4] be put in place, which should begin during the proposal stage.

 Additional Project Plan Requirements

The Project Plan shall:

• define the milestones for the project.[5]
• require a Software Test Plan which will delineate the types of verification that will be used and where it will be used in the development life cycle.

Additional Specification Phase Requirements

MicroTools shall:

• create an SRS for each PESS per MicroTools standard development process. Multiple requirements specifications can be contained in the document per the IEEE standard.
• create a software architecture document/drawing that address the 60601-1 requirements.[6]

Additional SQA Requirements

MicroTools shall document how we handle the separation requirements that exist between our SQA efforts and our design efforts. In addition, the professional relationships that exist between the members of the design team and SQA shall be documented in the Risk Management File.[7]

All problems from specification on through release shall be logged in a problem tracking system.

Additional Documentation Requirements

MicroTools shall:

• log all problems from specification on through release in a problem tracking system. 
• have all documents defined as deliverables in the Project Plan[8] reviewed, approved, and released within a configuration control environment.
• provide a formal document control system for all deliverable documents.[9]
• provide a structure diagram for the PEMS per 60601-1.[10]
• document revision changes in the header of all documentation, software files and schematics.[11]
• provide a technical description of networking capability of the PEMS per 60601-1.[12]

Miscellaneous Requirements

MicroTools should have a configuration management plan in place.[13]

Additional Specifications that can be called out

MicroTools must be conversant in the additional specification that 60601-1 invokes:

• 14971 Risk Management[14]
• IEC 60601-1-2 for Electromagnetic compatibility[15]
• IEC 60529 for enclosures[16]
• IEC 62366 Usability[17]
• IEC 60601-1-8 for alarm requirements[18]
• IEC 60950-1 for wire insulation requirements[19]
• IEC 60384-14 for capacitors[20]
• IEC 61058-1 for creepage distances and clearances
• IEC 60245 or IEC 60227 for power cords
• IEC 62304 for software development[21]
• IEC 60086-4 for lithium batteries
• A wide range of standards for marking and symbols
• Other standards for the particular industry – like POC[22] and power jacks, etc

Other standards are invoked to define the test conditions but do not directly affect your design except to tell you, for example, what are acceptable voltage spikes coming from the AC mains.

[1] ME EQUIPMENT or an ME SYSTEM containing one or more PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS)
[2] system based on one or more central processing units, including their software and interfaces
[3] 7.2.2
[4] 4.2 A RISK MANAGEMENT PROCESS complying with ISO 14971 shall be performed.
[5] 14.4
[6] 14.8
[7] 14.11
[8] Project Plan’s are required for all MicroTools projects under the standard development process.
[9] Clause 14.2
[10] H.1
[11] H.3.6
[12] 14.13
[13] H.3.5
[14] 4.2 A RISK MANAGEMENT PROCESS complying with ISO 14971 shall be performed.
[15] 4.10.2 IEC 60601-1-2 contains requirements and tests for voltage dips, short interruptions and voltage variations on the SUPPLY MAINS.
[16] ENCLOSURES shall be classified according to the degree of protection against harmful ingress of water and particulate matter as detailed in IEC 60529
[17] 7.1.1 The MANUFACTURER shall address in a USABILITY ENGINEERING PROCESS the RISK of poor USABILITY associated with the design of the ME EQUIPMENT identification, marking and documents.12.2 The MANUFACTURER shall address in a USABILITY ENGINEERING PROCESS the RISK of poor USABILITY including those associated with identification, marking and documents (see 7.1.1 and 16.2)
[18] 7.9.2.10 NOTE 2 Requirements and guidelines for messages generated by an alarm system are found in IEC 60601-1-8.
[19] 8.5.1.3 Solid insulation … shall comply with the requirements of IEC 60950-1 for INSULATION CO-ORDINATION.
[20] 8.5.1.3 A Y2 capacitor complying with IEC 60384-14 is considered equivalent to one MEANS OF OPERATOR PROTECTION provided that it will pass the dielectric strength test for one MEANS OF OPERATOR PROTECTION
[21] 14.4 NOTE 2 IEC 62304 [26] defines general requirements for additional PROCESSES and activities specific to software development.
[22] 4.8 They shall comply with one of the following (see also 4.5): a) the applicable safety requirements of a relevant IEC or ISO standard;