| Risk Assessment and Machine Design |
ISO 12100:2010 |
Documented hazard identification, risk estimation, risk reduction measures, and residual-risk information covering loading, wrapping, film cutting, maintenance, cleaning, and foreseeable misuse. |
Machine-specific risk assessment, technical file index, operating instructions, and residual-risk labels. |
Essential
The foundation for all other safety decisions. |
| Safety-Related Control Systems |
ISO 13849-1:2023 or IEC 62061:2021 |
Safety functions such as guard-door monitoring, emergency stopping, access protection, and restart prevention should have a documented Performance Level or Safety Integrity Level appropriate to the assessed risk. |
Safety-function list, validation report, circuit diagrams, safety-controller documentation, and component specifications. |
Essential
Prevents hazardous motion from depending on ordinary control logic alone. |
| Electrical Equipment |
IEC 60204-1:2016+A1:2021 |
Electrical equipment should include suitable disconnecting means, protective bonding, overcurrent protection, short-circuit protection, clearly identified conductors, and documented verification tests. |
Electrical drawings, test records, rated-voltage information, enclosure details, and protective-conductor continuity results. |
Essential
Important when equipment is installed in different voltage and frequency regions. |
| Guards and Physical Protection |
ISO 14120:2015 and ISO 13857:2019 |
Fixed and movable guards should prevent access to dangerous rotating, clamping, cutting, and conveying areas. Safety distances should be suitable for the identified body-part access risks. |
Guard drawings, access-distance calculations, fastener details, inspection checklist, and physical demonstration during factory acceptance testing. |
Essential
Particularly important around the turntable, film carriage, and powered conveyors. |
| Interlocked Access Doors |
ISO 14119:2024 |
Interlocked doors or gates should prevent hazardous operation when open and prevent automatic restart after access is closed unless a deliberate restart command is given. Guard-locking may be needed where stopping time creates a risk. |
Interlock type and coding information, stopping-time assessment, restart test, and validation records. |
Essential
Reduces exposure during film-threading and fault recovery. |
| Emergency Stop Function |
ISO 13850:2015 |
Emergency-stop devices should be readily accessible, clearly identifiable, manually reset, and designed to stop hazardous movement without creating additional hazards. Resetting must not initiate a restart. |
Emergency-stop layout, functional test record, reset logic description, and stop-category assessment. |
Essential
Provide devices at operator and service access points as justified by the risk assessment. |
| Packaging-Machine Safety |
EN 415-6:2013+A1:2019, where applicable |
For stretch-wrapping and related packaging equipment within its scope, the design should address access to wrapping zones, film carriages, rotating platforms, conveyors, and automatic product transfer. |
Applicability assessment, harmonized-standard declaration where relevant, safety design review, and guarding test results. |
High
Confirm the applicable edition and legal status in the destination market. |
| Unexpected Start-Up and Maintenance |
ISO 14118:2017; OSHA 29 CFR 1910.147 for applicable United States workplaces |
Energy-isolation provisions should cover electrical, pneumatic, hydraulic, gravity, stored mechanical, and thermal energy. Maintenance access should support lockout/tagout or the legally required equivalent. |
Isolation-point schedule, lockable disconnects, maintenance procedure, energy-control procedure, and service training records. |
Essential
Critical for film replacement, blade servicing, jam clearance, and cleaning. |
| Workplace Machine Guarding |
OSHA 29 CFR 1910.212 for applicable United States installations |
Point-of-operation and moving-machine-part hazards should be guarded, and the final installation should maintain safe clearances and accessible emergency controls. |
Site risk assessment, guarding inspection, installation drawings, and workplace acceptance records. |
High
Applies to the installed system, not only the machine as shipped. |
| European Union Market Access in 2026 |
Machinery Directive 2006/42/EC until 19 January 2027; Regulation (EU) 2023/1230 applies from 20 January 2027 |
For machines placed on the EU market during 2026, the manufacturer should complete the applicable conformity-assessment procedure, prepare technical documentation, issue an EU Declaration of Conformity, provide instructions, and apply the CE marking where required. |
EU Declaration of Conformity, CE marking information, instructions in the required language, technical-file summary, and applicable standards list. |
Essential
Confirm the legal regime based on the placing-on-market date. |
| Electromagnetic Compatibility |
Directive 2014/30/EU for applicable European Union installations; IEC 61000 series test methods may be used |
Controls, sensors, variable-speed drives, and safety circuits should operate reliably in the intended electromagnetic environment and should not cause unacceptable interference. |
EMC risk assessment, test report, installation instructions, cable-shielding requirements, and grounding instructions. |
High
Important in facilities with welders, large motors, radio systems, or multiple drives. |
| Materials and Restricted Substances |
RoHS Directive 2011/65/EU, where applicable |
Electrical and electronic assemblies supplied into covered markets should meet applicable restrictions on hazardous substances and maintain the required supply-chain documentation. |
RoHS declaration, material declarations, supplier records, and product-specific compliance statement. |
Medium–High
Check whether the complete machine or only specific electrical assemblies fall within scope. |
| Functional Performance and Throughput |
Machine specification and validated factory-acceptance criteria; no single universal speed is mandated by the standards listed |
Published cycle rate should state pallet dimensions, load height, film type, wrap pattern, rotation speed, acceleration limits, and whether loading and unloading time are included. |
Witnessed cycle test using representative loads, recorded cycle times, film-consumption data, and acceptance tolerances. |
High
Compare like-for-like conditions rather than headline cycles per hour. |
| Load Stability and Wrapping Quality |
ASTM D4649 and ASTM D5414 may support evaluation of stretch-film performance; application-specific test methods should be agreed |
The system should provide repeatable film tension, controlled overlap, consistent top and bottom reinforcement, and a wrapping recipe suitable for the load geometry and distribution conditions. |
Load-stability test, film-force or containment-force records, transport simulation where required, and approved recipe parameters. |
High
The correct result depends on the load, film, transport route, and environmental conditions. |
| Film-Cutting and Sealing Safety |
ISO 12100, ISO 13849-1, ISO 14120, and ISO 14119 as applicable |
Automatic film-cutting or heat-sealing areas should be guarded or interlocked, with safe access for threading and maintenance. Hot-surface and sharp-edge risks should be identified and controlled. |
Cut-and-seal risk assessment, temperature controls, guarding test, burn-risk warning, and maintenance instructions. |
High
Do not assess wrapping speed without reviewing the film-handling hazards. |
| Operator Information and Training |
ISO 20607:2019 and applicable local machinery legislation |
Instructions should cover intended use, prohibited use, setup, film threading, recipe selection, emergency response, fault recovery, cleaning, inspection, maintenance, and residual risks. |
Operating manual, maintenance manual, warning labels, training records, and language-specific documentation. |
Essential
Documentation must match the delivered configuration and control software. |
| Site Integration and Safety Zones |
ISO 12100, ISO 13857, ISO 13849-1, and applicable local workplace regulations |
Layout should define operator clearance, pallet-infeed and outfeed zones, forklift interfaces, pedestrian separation, light curtains or scanners where required, and safe access for service. |
General-arrangement drawing, safety-zone layout, interface responsibility matrix, and installation acceptance checklist. |
Essential
A compliant machine can become unsafe if integrated incorrectly. |
| Environmental Suitability |
IEC 60529 for enclosure ingress protection classification; manufacturer-rated operating conditions |
Electrical enclosures, sensors, drives, and controls should have an ingress-protection rating suitable for dust, moisture, washdown, temperature, and humidity at the installation site. |
IP-rating documentation, environmental operating range, washdown limitations, enclosure inspection, and site-condition review. |
High
Food, chemical, cold-storage, and dusty warehouses may require different protection levels. |
| Electrical Supply Compatibility |
IEC 60204-1 and local electrical installation requirements |
The quotation should identify rated voltage, phase, frequency, full-load current, short-circuit rating assumptions, compressed-air requirements if used, and permitted supply tolerances. |
Data sheet, nameplate, electrical schematic, utility schedule, and pre-installation compatibility check. |
Essential
Prevents commissioning delays caused by incompatible utilities. |
| Traceability and Change Control |
Technical-file and quality-management practices; applicable conformity legislation |
Safety components, software versions, electrical drawings, bills of material, and approved modifications should be traceable to the delivered machine serial or configuration record. |
As-built drawings, software backup, component list, revision history, spare-parts list, and final conformity documentation. |
High
Supports audits, troubleshooting, spare-parts planning, and future modifications. |
