PROJECT DESIGN SPECIFICATIONS
PRS
Category
Requirement
PRS:
Put ID code for the design specification entry
Category:
Put a group number for specifying the category listed in the appendix
Requirement:
Describe the design specification, include the target numerical value when applicable
Source:
Indicate the source of the specification (and the target numerical value)
Source
APPENDIX
The following categories provide guidance for possible project requirement specifications. The list is not all
inclusive, and categories may overlap in certain applications. Do not edit this appendix.
1.) BUSINEES REQUIREMENTS (derived from business guidance)
Considerations for Guidance:
 Requirements of cost (expectations or restrictions)
 Requirements of compatibility or modularity with other products.
 Requirements of placing the product within the corporate product line.
 Requirements of design to maintain a consistent corporate identification.
2.) CUSTOMER REQUIREMENTS (derived from market analysis)
Considerations for Guidance:
 Requirements identified through market analysis.
 Requirements of geographical/regional markets.
3.) PRODUCT REQUIREMENTS
Considerations for Guidance:
 Requirements for product size(s), configurations, features, mechanical interfaces, etc.
 Requirements for design features (i.e. size, shape, colors, surface finish, mating features for other instruments,
anatomical fit, etc.).
 Requirements for the mechanical form, fit, or function of the system.
 Requirements for measurement – display, accuracy, repeatability, calibration, and interpretation of
measurements.
 Requirements for electronic components, circuitry, or firmware (i.e. battery life, PCB size, wireless vs. wired, etc.).
4.) USABILITY REQUIREMENTS
Considerations for Guidance:
 Requirements for human factors (readability, interpretability, function in a given environment, etc.)
 Requirements for ergonomics (sizes, human fits, repetitive motions, accessibility, special user needs, etc.)
 Requirements for indications or contraindications for use.
 Requirements for usability testing of marketing claims (i.e. this product out performs others – test it)
 Requirements for validation of training methods or instructions.
 Requirements for validation of use environment (does it perform in stated environment).
5.) MATERIAL REQUIREMENTS
Considerations for Guidance:
 Requirements of material mechanical properties (density, strength, elongation, viscosity, wear resistance,
hardness, and fatigue)
 Requirements of material thermal properties (thermal conductivity, specific heat capacity, glass transition temp,
melt temp)
 Requirements of material environmental properties (dielectric constant, water absorption, UV stability,
outgassing)
 Requirements for material compatibility and testing (biocompatibility, galvanic compatibility, etc.)
6.) SOFTWARE REQUIREMENTS (This can be a complete separate software requirement specification)
Considerations for Guidance:
 Requirements of software operations, functions, and performance.
 Requirements of software architecture and platform integration.
 Requirements of software inputs and outputs.
 Requirements of software data storage and retrieval.
 Requirements of software user interfaces.
7.) PACKAGING REQUIREMENTS
Considerations for Guidance:
 Requirements for packaging form, fit, or function. (size, components in the package, protection of product,
product retailer display)
 Requirements for packaging materials and compatibilities. (environmentally friendly, transparent, etc.)
 Requirements for shelf life of packaging. (bio-degradable, aging, UV stability, heat resistant, etc.)(must be
longer than expected shelf life of product).
 Requirements for packaging to withstand shipping, handling, and transport.
 Requirements for packaging strength (seal integrity, sterility, tamper proof, stacking, crushing, dropping).
 Requirements for packaging aesthetics (printed packaging, product specifications, selling points)
8.) LABELING REQUIREMENTS
Considerations for Guidance:
 Requirements for label information (product identification, unique product identifier, regulatory markings,
manufacturer identification, recycling codes)
 Requirements for label location, size, print size, color.
 Requirements for manuals, warnings, instructions, warrantee information, technical updates, included software
sleeves, disposal instructions, recycling instructions, etc.
9.) ENVIRONMENTAL REQUIREMENTS
Considerations for Guidance:
 Requirements for use (single use, multiple use, sterile, disposable)
 Requirements for cleaning/sterilizing to include instructions, validation, sterility assurance level, etc.
 Requirements for disposal considerations.
 Requirements for environmentally friendly manufacturing processes.
10.) PRODUCT LIFETIME REQUIREMENTS
Considerations for Guidance:
 Requirements for wear or end of life determination.
 Requirements for installation, servicing, scheduled maintenance, refurbishment, repair kits, etc.
 Requirements for obsolescence.
 Requirements for environmentally friendly manufacturing processes.
11.) SAFETY REQUIREMENTS
Considerations for Guidance:
 Requirements for level of risk allowable.
 Safety requirements derived from the HID.
 Requirements for electrical safety.
 Requirements for usability safety (no sharp edge, burrs, ergonomic safety issue, etc.)
12.) REGULATORY REQUIREMENTS
Considerations for Guidance:
 Requirements for safety and effectiveness required by regulatory agencies and/or regulations.
 Requirements for post market surveillance.
 Requirements for safety certifications (CSA, UL, EMC, EMI, etc.).
 Requirements disposal regulations (ROHS, WEE).
13.) ADDITIONAL REQUIREMENTS
Consider additional requirements as necessary.